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Pulmonary artery sarcoma (PAS), although rare, must be considered in the differential diagnosis of pulmonary thromboembolism (PTE). This tumor is highly malignant and the prognosis is very poor. As much as the standardized uptake values (SUVs) at fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG PET) have helped in differentiating between benign and malignant tumors, visualization of a low-attenuation filling defect within a pulmonary artery on contrast-enhanced chest computed tomography (CT) can be suggestive of a malignancy, such as PAS, if the lesion shows high FDG uptake at PET. We present a case of PAS that showed high FDG uptake on integrated FDG PET/CT and with lung metastasis. Patient underwent endoscopic bronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA), which confirmed spindle cell sarcoma. [ABSTRACT FROM AUTHOR]

Pulmonary sclerosing hemangioma (PSH), or the alternative name of "sclerosing pneumocytoma," is a rare benign neoplasm. PSH is often asymptomatic and presents as a solitary or multiple pulmonary nodules on radiologic imaging studies. Few articles have been reported to describe the fluorodeoxyglucose positron emission tomography (FDG PET) findings about PSH. The authors describe an interesting but uncommonly encountered cause of false positive FDG PET scan in the thorax in a 25-year-old woman, a known case of arteriovenous malformation of oral cavity who underwent embolization and presented with incidental detection of bilateral lung nodules. She is asymptomatic and is on follow-up. [ABSTRACT FROM AUTHOR]

Background: Rhenium-188-labelled-Lipiodol radioembolization is a safe and cost-effective treatment for primary liver cancer. In order to determine correlations between treatment doses and patient response to therapy, accurate patient-specific dosimetry is required. Up to date, the reported dosimetry of 188Re-Lipiodol has been based on whole-body (WB) planar imaging only, which has limited quantitative accuracy. The aim of the present study is to determine the in vivo pharmacokinetics, bio-distribution, and organ-level dosimetry of 188Re-AHDD-Lipiodol radioembolization using a combination of post-treatment planar and quantitative SPECT/CT images. Furthermore, based on the analysis of the pharmacokinetic data, a practical and relatively simple imaging and dosimetry method that could be implemented in clinics for 188Re-AHDD-Lipiodol radioembolization is proposed.Thirteen patients with histologically proven hepatocellular carcinoma underwent 188Re-AHDD-Lipiodol radioembolization. A series of 2-3 WB planar images and one SPECT/CT scan were acquired over 48 h after the treatment. The time-integrated activity coefficients (TIACs, also known as residence-times) and absorbed doses of tumors and organs at risk (OARs) were determined using a hybrid WB/SPECT imaging method.Results: Whole-body imaging showed that 188Re-AHDD-Lipiodol accumulated mostly in the tumor and liver tissue but a non-negligible amount of the pharmaceutical was also observed in the stomach, lungs, salivary glands, spleen, kidneys, and urinary bladder. On average, the measured effective half-life of 188Re-AHDD-Lipiodol was 12.5 ± 1.9 h in tumor. The effective half-life in the liver and lungs (the two organs at risk) was 12.6 ± 1.7 h and 12.0 ± 1.9 h, respectively. The presence of 188Re in other organs was probably due to the chemical separation and subsequent release of the free radionuclide from Lipiodol.The average doses per injected activity in the tumor, liver, and lungs were 23.5 ± 40.8 mGy/MBq, 2.12 ± 1.78 mGy/MBq, and 0.11 ± 0.05 mGy/MBq, respectively. The proposed imaging and dosimetry method, consisting of a single SPECT/CT for activity determination followed by 188Re-AHDD-Lipiodol clearance with the liver effective half-life of 12.6 h, resulted in TIACs estimates (and hence, doses) mostly within ± 20% from the reference TIACs (estimated using three WB images and one SPECT/CT).Conclusions: The large inter-patient variability of the absorbed doses in tumors and normal tissue in 188Re-HDD-Lipiodol radioembolization patients emphasizes the importance of patient-specific dosimetry calculations based on quantitative post-treatment SPECT/CT imaging. [ABSTRACT FROM AUTHOR]

Gliomatosis cerebri (GC) is a rare condition in which an infiltrative glial neoplasm spreads through the brain with preservation of the underlying structure. F-18 fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) has an important role in demonstrating the appropriate metabolism and differentiating pathologies mimicking GC on CT and magnetic resonance imaging. We describe imaging findings of FDG PET/CT in GC in a 9-year-old male child mimicking encephalitis. [ABSTRACT FROM AUTHOR]

Cutaneous metastases from internal malignancies are rare with a reported incidence between 0.7% and 10%. It may be the first symptom in 7% of the patients with cancer. We report a case with distant solitary skin metastases in anterior abdominal skin from breast cancer detected on F-fluorodeoxyglucose-positron emission tomography/computed tomography imaging. [ABSTRACT FROM AUTHOR]

Post-transplant lymphoproliferative disorder (PTLD) is a heterogeneous group of lymphoid proliferations caused by immunosuppression after solid organ or bone marrow transplantation. PTLD is categorized by early lesion, polymorphic PTLD and monomorphic PTLD. Fluorine-18 fluorodeoxyglucose-positron emission tomography/computed tomography (F-18 FDG-PET/CT) scans have clinical significance in the evaluation of PTLD following renal transplantation. We report imaging findings of a monomorphic non-Hodgkin lymphoma, post renal transplant seen on FDG PET/CT in a 32-year-old lactating woman. Whole body FDG- ET/CT demonstrated uptake in right external iliac and inguinal lymph nodes. [ABSTRACT FROM AUTHOR]

Gestational or pregnancy-associated breast cancer is defined as breast cancer that is diagnosed during pregnancy, in the first post-partum year or any time during lactation. We report a rare imaging finding of breast cancer seen on fluorodeoxyglucose-positron emission tomography/computed tomography (FDG PET/CT) study in a 32-year-old lactating woman. The FDG PET/CT study demonstrated uptake in the soft tissue lesion noted in the right breast corresponding to the primary lesion and multiple nodes in the bilateral axilla, right supraclavicular and mediastinum. In addition, there was FDG tracer uptake in both the breast parenchyma related to breast feeding. This case illustrates the first case of breast cancer in a lactating woman described in FDG PET/CT. [ABSTRACT FROM AUTHOR]

Trilateral retinoblastoma (TRb) is a rare syndrome associating hereditary bilateral or unilateral retinoblastoma (Rb) with an intracranial neuroblastic tumor. The latter arises in the midline, most often in the pineal gland, less frequently in the suprasellar or parasellar region. The outcome is usually fatal because of secondary spinal dissemination. We report 10-year-old boy presented with a right eye proptosis and leukocoria, and the magnetic resonance imaging (MRI) showed right orbital mass lesion infiltrating optic nerve and diagnosis of retinoblastoma was made. He was referred for fluorodeoxyglucose-positron emission tomography/computed tomography (FDG PET/CT) to find out the extent of the disease. PET/CT showed abnormal FDG-uptake within right orbital mass lesion, suprasellar enhancing lesion and drop metastasis in the cervical spinal canal level. He was diagnosed as a case of TRb with spinal canal drop metastasis. He underwent chemotherapy and craniospinal irradiation. [ABSTRACT FROM AUTHOR]

Differentiated thyroid cancer frequently metastasizes but generally spreads to regional cervical lymph nodes and, in advanced cases, to the lungs and/or skeleton. Metastases to the skin/subcutaneous tissue are rare. We report 45-year-old male patient presented with a loin swelling which on biopsy showed a papillary carcinoma and referred for fluorodeoxyglucose-positron emission tomography/computed tomography (FDG PET/CT) to find out the primary disease. PET/CT showed abnormal FDG uptake within a loin metastasis and right lobe thyroid nodule. Fine-needle aspiration from nodule showed papillary carcinoma. Because thyroid cancer can rarely metastasize to the skin, attention should be given to that region during interpretation of the images. He was advised total thyroidectomy and metastasis excision. [ABSTRACT FROM AUTHOR]

Fluorodeoxyglucose-positron emission tomography/computed tomography (FDG PET/CT) has proven useful in the diagnosis, staging, and detection of metastasis and posttreatment monitoring of several malignancies in human immunodeficiency virus (HIV)-infected patients. It also has the ability to make the important distinction between malignancy and infection in the evaluation of central nervous system (CNS) lesions, leading to the initiation of the appropriate treatment and precluding the need for invasive biopsy. We report an interesting case of HIV positive 35-year-old woman presented with headache, disorientation, and decreased level of consciousness. She underwent whole body PET/CT which showed multiple lesions in the cerebrum which mimics bilateral eye in brain. A diagnosis of a primary CNS lymphoma was made and patient was started on chemotherapy. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented related to a case study of a patient with lung cancer detected with fluorine-18 fluorodeoxyglucose-positron emission tomography/computed tomography (F-18 FDG PET/CT) and magnetic resonance imaging (MRI) in a previous issue.

Cases of primary neuroendocrine carcinoma (NEC) of the breast have been reported, though rare. We report the case of a 45-year-old woman presented with jaundice and evaluated to have liver metastasis from neuroendocrine origin. She underwent whole body positron emission tomography/computed tomography, which showed left breast lesion and bone metastasis. Fine-needle aspiration (FNA) of breast revealed a NEC. A diagnosis of a primary NEC of the breast was rendered with hepatic and bone metastasis. She was treated with peptide receptor radionuclide therapy and is on follow-up. [ABSTRACT FROM AUTHOR]

Lipomatous hypertrophy of the interatrial septum (LHIS) is a relatively uncommon disorder of the heart characterized by benign fatty infiltration of the interatrial septum that usually spares the fossa ovalis. LHIS showing flurodeoxyglucose uptake has been reported, and is presumed to be due to activated brown adipose tissue (BAT). We here report a case of a patient who had isolated mediastinal uptake in interatrial septum, mimicking metastasis. Rescanning with external warming to deactivate BAT and a delayed time point image was done, which showed persistent and progressively increasing metabolic uptake respectively, suggesting that LHIS uptake might be unrelated to activated BAT or inflammation. [ABSTRACT FROM AUTHOR]

We report a case of 79-year-old male with prostate cancer and coagulation disorder presented with left shoulder pain. He underwent bone scintigraphy to rule out metastasis, which showed intense foci of tracer activity in the left axilla. Hybrid single-photon emission tomography-computed tomography (SPECT/CT) of the shoulder region localized tracer uptake to the left brachialis muscle hematoma. [ABSTRACT FROM AUTHOR]

A letter to the editor related to bone metastasis detection using hydrazinonicotinyl-Tyr3-octreotide (HYNIC-TOC) single-photon emission computed tomography/computed tomography (SPECT/CT) in the previous issue is presented.

We report a rare case of isolated splenic metastasis from gastric cancer detected with fluorine-18 fluorodeoxyglucosepositron emission tomography/computed tomography (PET/CT). A 55-year-old man with gastric cancer 1 year post surgery, evaluated with PET/CT showed focal, intense uptake in the spleen, with no other abnormal findings. On splenectomy, the lesion was confirmed as metastasis from gastric cancer pathologically. [ABSTRACT FROM AUTHOR]

The article presents the author's views on the life of nuclear medicine physicians and death of Dr. Padhy. As mentioned, Dr. Padhy was the founder of Rhenium-188 (Re-188) Lipiodol-based transarterial radioembolization (TARE) procedure. Various other topics discussed includes WARMTH Rhenium Project, treatment of liver cancer and first World Rhenium Conference that was held in Coimbator, India.

Introduction The scope of using no carrier added (NCA) 90 Y [T 1/2 = 64.1 h, E β(max) = 2.28 MeV] obtained from 90 Sr/ 90 Y generator in radiation synovectomy (RSV) is widely accepted. In the present study, the prospect of using 90 Y produced by (n,γ) route in a medium flux research reactor for use in RSV was explored. Methods Yttrium-90 was produced by thermal neutron irradiation of Y 2 O 3 target at a neutron flux of ~ 1 × 10 14 n/cm 2 .s for 14 d. The influence of various experimental parameters were systematically investigated and optimized to arrive at the most favorable conditions for the formulation of 90 Y labeled hydroxyapatite (HA) using HA particles of 1–10 μm size range. An optimized kit formulation strategy was developed for convenient one-step compounding of 90 Y-HA, which is easily adaptable at hospital radiopharmacy. The pre-clinical biological evaluation of 90 Y-HA particles was studied by carrying out biodistribution and bioluminiscence imaging studies in Wistar rats. The first clinical investigation using the radiolabeled preparation was performed on a patient suffering from chronic arthritis in knee joint by administering 185 MBq 90 Y-HA formulated at the hospital radiopharmacy deploying the proposed strategy. Results Yttrium-90 was produced with a specific activity of 851 ± 111 MBq/mg and radionuclidic purity of 99.95 ± 0.02%. 90 Y-labeled HA particles (185 ± 10 MBq doses) were formulated in high radiochemical purity (> 99%) and excellent in vitro stability. The preparation showed promising results in pre-clinical studies carried out in Wistar rats. The preliminary results of the first clinical investigation of 90 Y-HA preparation in a patient with rheumatoid arthritis in knee joints demonstrated the effectiveness of the formulation prepared using 90 Y produced via (n,γ) route in the management of the disease. Conclusion The studies revealed that effective utilization of 90 Y produced via (n,γ) route in a medium flux research reactor coupled with the developed strategy of using HA kits for convenient formulation of 90 Y-HA at the hospital radiopharmacy can contribute to sustainable growth in the clinical utilization of 90 Y in RSV in the foreseeable future. [ABSTRACT FROM AUTHOR]

Background: Rhenium-188( 188 Re)-lipiodol is a clinically effective, economically viable radiopharmaceutical for Selective Internal Radiation Therapy of liver cancer. Present study evaluates the performance of three freeze-dried kits with respect to the radiochemistry, quality control, and overall "ease of preparation" aspects in a hospital radiopharmacy. Materials and Methods: Freeze-dried kits of acetylated 4-hexadecyl-4,7-diaza-1,10-decanedithiol (AHDD), super six sulfur (SSS), and diethyl dithiocarbamate (DEDC), obtained commercially or received as gift, were used for the preparation of 188 Re-lipiodol using freshly eluted 188 Re-sodium perrhenate from commercial Tungsten-188/ 188 Re generator following recommended procedures. Results: The overall yield of 188 Re-lipiodol prepared using AHDD Kit, SSS Kit, and DEDC Kit was 74.82% ± 3.3%, 87.55% ± 4.8%, and 76.38% ± 4.6%, respectively. Observed radiochemical purity (RCP) of 188 Re-lipiodol prepared using these kits was 88.65% ± 2.8%, 92.92% ± 3.0%, and 91.38% ± 3.0%, respectively. Using a modified version of the DEDC Kits, overall yield of 87.17% ± 2.7% and RCP of 95.43% ± 2.3% could be achieved. Conclusions: While all three freeze-dried kits can be used for the preparation of 188 Re-lipiodol in >70% overall yield, the modified version of DEDC Kits has some advantages in terms of preparation time and volume of Rhenium-188 activity that can be added to the kit vial. The latter feature of the DEDC Kit is particularly useful for patient dose preparation with 188 Re activity of low radioactive concentration.

Hepatocellular carcinoma (HCC) is a global killer with preponderance in Asian and African countries. It poses a challenge for successful management in less affluent or developing nations like India, with large populations and limited infrastructures. This review aims to assess the available options and future directions for management of HCC applicable to such countries. While summarizing current and emerging clinical strategies for detection, staging and therapy of the disease, it highlights radioisotope- and radioactivity-based strategies as part of an overall program. Using the widely accepted Barcelona Clinic Liver Cancer (BCLC) staging system as a base, it evaluates the applicability of different therapeutic approaches and their synergistic combination(s) in the context of a patient-specific dynamic results-based strategy. It distills the conclusions of multiple HCC management-focused consensus recommendations to provide a picture of clinical strategies, especially radiation-related approaches. Additionally, it discusses the logistical and economic feasibility of these approaches in the context of the limitations of the burdened public health infrastructure in India (and like nations) and highlights possible strategies both at the clinical level and in terms of an administrative health policy on HCC to provide the maximum possible benefit to the widest swathe of the affected population., (© 2021. The Author(s).)

Objective: This study aimed to assess the potential benefits and tolerability of an empirical dose of approximately 0.8-1.2 mCi (29.6-44.4 MBq) of Re-4-hexadecyl-1-2,9,9-tetramethyl-4,7-diaza-1,10-decanethiol/lipiodol (Re-HDD/lipiodol) per milliliter of tumor volume, administered after super-selection of the tumor feeding branches of hepatic artery for treatment of inoperable hepatocellular carcinoma (HCC)., Methods: Patients with advanced HCC or classified as inoperable, with no demonstrated extrahepatic disease and no significant comorbidities were eligible. The patients selected for this study had a single tumoral lesion, measuring less than 150 cc. The range of total activity administered was between 30 and 100 mCi (1.2-3.7) GBq Re-HDD/lipiodol, administered in the super selected branches of the hepatic artery supplying the tumor in 42 Patients. Whole-body scintigraphies and single-photon emission computed tomography-computed tomography (SPECT-CT) of the liver including tumor were performed at four-time points after injection. Absorbed doses to the various organs were calculated according to the Medical Internal Radiation Dose formalism. Blood and urine samples were collected at multiple time points until 72 h after injection. Hematological, hepatic and pulmonary toxicity was assessed until 12 weeks after administration using the Common Toxicity Criteria for Adverse Events (version 3.0) scale. Responses were evaluated on contrast enhanced computed tomography (CECT) and by alfa-fetoprotein (AFP) level monitoring., Results: About 40.6 ± 4.8% of the injected activity was excreted in the urine by 72 h after injection. The mean absorbed dose to the liver, lungs, stomach, kidney and intestine was 14.4 ± 1.8, 4.8 ± 0.6, 5.5 ± 1.1, 5.1 ± 0.7, and 6.5 ± 1.0 Gy (mean ± SD), respectively. Up to 6 days after administration, 26 of 44 patients had adverse events consisting of aggravations of preexisting laboratory changes (24 patients), fatigue (5 patients), vomiting (6 patients), fever (2 patients), right hypochondrial pain (8 patients), and pain at site of femoral catheter insertion (8 patients). Toxicity assessment at weeks 6 and 12 revealed two cases of mild worsening of liver function tests and no lung or hematological toxicity noted. Two patients were lost to follow-up after the 6-week visit. The response was assessed on CECT in all the remaining patients and the classification of results was more standardized when using European Association for the Study of the Liver (EASL) criteria rather than response evaluation criteria in solid tumors (RECIST) criteria. According to EASL criteria, 8 patients had a partial response, 28 patients had a complete response, 4 patients had progressive disease and 4 patients with stable disease were reported. Thirty-six patients had a baseline elevated AFP and on follow-up at 6 weeks, 6 of these patients showed stable AFP, progression in 4 patients and 26 showed a reduction., Conclusion: After the administration of 1.2-3.7 GBq Re-HDD/lipiodol based on empirical activity calculation of 0.8-1.2 mCi/mL of tumor volume, more than half of the patients in the present study had an objective response on imaging and biochemically. No significant adverse side effects were noted and most of the laboratory markers as well as symptoms returned to normal after 48-72 h post-administration. Selective administration of the radiopharmaceutical into the tumor feeding arteries gives a good anti-tumoral effect with minimal side effects and damage to surrounding normal liver tissue.

Aim: To formulate freeze dried cold kits for preparation of 99m Tc-HYNIC-TATE suitable for use at hospital radiopharmacy and establish clinical utility of 99m Tc-HYNIC-TATE prepared using kits for detection of neuroendocrine tumors (NETs)., Methods: Standardization of reagent concentrations for formulation of freeze dried kits of HYNIC-TATE was carried out. Consistency in formulation was tested by six batch preparation. Quality control tests were carried out to establish compliance of specifications of purity and safety criteria for both kits and 99m Tc-HYNIC-TATE formulated using kits. Clinical utility of 99m Tc-HYNIC-TATE prepared using kits was demonstrated in patients with histopathologically confirmed well-differentiated NETs., Results: Pharmaceutical grade HYNIC-TATE kits compliant with all the quality control criteria were formulated and successfully radiolabeled with 99m Tc. Radiopharmaceutical was successfully utilized for detection of NETs in patients and comparison with uptake of 99m Tc-HYNIC-TOC and 177 Lu-DOTA-TATE was made., Conclusion: The formulated kits are robust and provide consistently high radiolabeling yields (> 95%) with 99m Tc in short time periods requiring no additional purification. Initial clinical trials demonstrate the utility of 99m Tc-HYNIC-TATE using formulated kits., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Purpose: 68 Ga-BPAMD has recently emerged as one of the preferred radiopharmaceuticals for imaging of bone lesions due to its ability to produce high-resolution images and uncomplicated availability of 68 Ga, a positron emission tomography (PET) radionuclide, from commercial 68 Ge/ 68 Ga generators. The primary objective of this work is to develop freeze-dried BPAMD kit, for the easy and convenient formulation of 68 Ga-BPAMD patient dose at the hospital radiopharmacy. In addition, the kit should be compatible with 68 Ga, eluted using HCl of various molarities from the 68 Ge/ 68 Ga generators sourced from different suppliers., Procedures: Freeze-dried BPAMD kit, comprising 50 μg of BPAMD and 150 mg of HEPES, was prepared and evaluated using 68 Ga eluted from three different 68 Ge/ 68 Ga generators. Radiochemical purity (RCP) of 68 Ga-BPAMD was determined by both thin-layer chromatography and high-performance liquid chromatography studies. The maximum volume of 68 Ga, which can be added in the kit, was determined. The biological behavior of 68 Ga-BPAMD, prepared using the freeze-dried kit, was evaluated by both in vitro and in vivo studies. Clinical studies were also performed in limited number of patients suffering from metastatic bone cancer., Results: 68 Ga-BPAMD could be prepared with >95% RCP using the freeze-dried BPAMD kit and 68 Ga eluted from 68 Ge/ 68 Ga generators obtained from three different suppliers. 68 Ga-BPAMD, prepared using the freeze-dried kit, exhibited adequate serum stability and ∼91% binding with the hydroxyapatite particles. Biodistribution studies in normal Wistar rats exhibited selective uptake of the agent in skeleton and fast clearance of the nonaccumulated activity through urinary route. Clinical studies in cancer patients showed excellent accumulation of the agent in bone lesions., Conclusion: The preliminary studies exhibited the potential of the developed BPAMD kit toward its utilization for the PET scanning of skeletal metastases.

Background: Rhenium-188-labelled-Lipiodol radioembolization is a safe and cost-effective treatment for primary liver cancer. In order to determine correlations between treatment doses and patient response to therapy, accurate patient-specific dosimetry is required. Up to date, the reported dosimetry of 188 Re-Lipiodol has been based on whole-body (WB) planar imaging only, which has limited quantitative accuracy. The aim of the present study is to determine the in vivo pharmacokinetics, bio-distribution, and organ-level dosimetry of 188 Re-AHDD-Lipiodol radioembolization using a combination of post-treatment planar and quantitative SPECT/CT images. Furthermore, based on the analysis of the pharmacokinetic data, a practical and relatively simple imaging and dosimetry method that could be implemented in clinics for 188 Re-AHDD-Lipiodol radioembolization is proposed. Thirteen patients with histologically proven hepatocellular carcinoma underwent 188 Re-AHDD-Lipiodol radioembolization. A series of 2-3 WB planar images and one SPECT/CT scan were acquired over 48 h after the treatment. The time-integrated activity coefficients (TIACs, also known as residence-times) and absorbed doses of tumors and organs at risk (OARs) were determined using a hybrid WB/SPECT imaging method., Results: Whole-body imaging showed that 188 Re-AHDD-Lipiodol accumulated mostly in the tumor and liver tissue but a non-negligible amount of the pharmaceutical was also observed in the stomach, lungs, salivary glands, spleen, kidneys, and urinary bladder. On average, the measured effective half-life of 188 Re-AHDD-Lipiodol was 12.5 ± 1.9 h in tumor. The effective half-life in the liver and lungs (the two organs at risk) was 12.6 ± 1.7 h and 12.0 ± 1.9 h, respectively. The presence of 188 Re in other organs was probably due to the chemical separation and subsequent release of the free radionuclide from Lipiodol. The average doses per injected activity in the tumor, liver, and lungs were 23.5 ± 40.8 mGy/MBq, 2.12 ± 1.78 mGy/MBq, and 0.11 ± 0.05 mGy/MBq, respectively. The proposed imaging and dosimetry method, consisting of a single SPECT/CT for activity determination followed by 188 Re-AHDD-Lipiodol clearance with the liver effective half-life of 12.6 h, resulted in TIACs estimates (and hence, doses) mostly within ± 20% from the reference TIACs (estimated using three WB images and one SPECT/CT)., Conclusions: The large inter-patient variability of the absorbed doses in tumors and normal tissue in 188 Re-HDD-Lipiodol radioembolization patients emphasizes the importance of patient-specific dosimetry calculations based on quantitative post-treatment SPECT/CT imaging.

188 Rhenium-hydroxyethylidene-1,1-diphosphonate ( 188 Re-HEDP) is a clinically established radiopharmaceutical for bone pain palliation of patients with metastatic bone cancer. Herein, the effectiveness of 188 Re-HEDP for the palliation of painful bone metastases was investigated in an uncontrolled initial trial in 48 patients with different types of advanced cancers. A group of 48 patients with painful bone metastases of lung, prostate, breast, renal, and bladder cancer was treated with 2.96-4.44 GBq of 188 Re-HEDP. The overall response rate in this group of patients was 89.5%, and their mean visual analog scale score showed a reduction from 9.1 to 5.3 ( P < 0.003) after 1 week posttherapy. The patients did not report serious adverse effects either during intravenous administration or within 24 h postadministration of 188 Re-HEDP. Flare reaction was observed in 54.2% of patients between day 1 and day 3. There was no correlation between flare reaction and response to therapy ( P < 0.05). Although bone marrow suppression was observed in patients receiving higher doses of 188 Re-HEDP, it did not result in any significant clinical problems. The present study confirmed the clinical utility and cost-effectiveness of 188 Re-HEDP for palliation of painful bone metastases from various types of cancer in developing countries., Competing Interests: There are no conflicts of interest.

This study explores the possibility of formulation of a cold kit for fast and easy preparation of a PET radiopharmaceutical, 68 Ga-NOTA-UBI (29-41) for clinical translation. In this study, Circular dichroism (CD) spectroscopy to study conformation of NOTA-UBI (29-41) and its comparison with conformation of UBI (29-41) was done. Pharmaceutical grade cold kits of NOTA-UBI (29-41) were formulated for radiolabeling with 68 Ga and necessary quality control tests were carried out. 68 Ga-NOTA-UBI (29-41) could be prepared in >90% radiochemical yield and radiochemical purity using cold kits of NOTA-UBI (29-41). In vitro and in vivo evaluation of 68 Ga-NOTA-UBI (29-41) was done to demonstrate specificity of the agent for imaging infection. Kits were utilized for preparation of patient dose of 68 Ga-NOTA-UBI (29-41). Simple instant thin layer chromatography (ITLC) method for estimating radiolabeling yield of 68 Ga-NOTA-UBI (29-41) at hospital radiopharmacy was demonstrated. Clinical evaluation was done in patients with suspected infection. 148-185 MBq of 68 Ga-NOTA-UBI (29-41) was injected intravenously in three patients. 68 Ga-NOTA-UBI (29-41) uptake could clearly delineate infection foci from non target normal tissues. This is the first report on formulation of a cold kit of NOTA-UBI (29-41) for preparation of 68 Ga labeled NOTA-UBI(29-41) at hospital radiopharmacy for infection imaging. Initial clinical evaluation reveal it to be a prospective agent for imaging infection., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Introduction: Gallium-68 based infection imaging agents are in demand to detect infection foci with high spatial resolution and sensitivity. In this study, Ubiquicidin derived octapeptide, UBI (31-38) conjugated with macrocyclic chelator NOTA was radiolabeled with 68 Ga to develop infection imaging agent., Methods: Circular dichroism (CD) spectroscopy was performed to study conformational changes in UBI (31-38) and its NOTA conjugate in a "membrane like environment". Radiolabeling of NOTA-UBI (31-38) with 68 Ga was optimized and quality control analysis was done by chromatography techniques. In vitro evaluation of 68 Ga-NOTA-UBI (31-38) in S. aureus and preliminary biological evaluation in animal model of infection was studied. Initial clinical evaluation in three patients with suspected infection was carried out., Results: 68 Ga-NOTA-UBI (31-38) was prepared in high radiochemical yields and high radiochemical purity. In vitro evaluation of 68 Ga-NOTA-UBI (31-38) complex in S. aureus confirmed specificity of the agent for bacteria. Biodistribution studies with 68 Ga-NOTA-UBI (31-38) revealed specific uptake of the complex in infected muscle compared to inflamed muscle with T/NT ratio of 3.24 ± 0.7 at 1 h post-injection. Initial clinical evaluation in two patients with histopathologically confirmed infective foci conducted after intravenous injection of 130-185 MBq of 68 Ga-NOTA-UBI (31-38) and imaging at 45-60 min post-injection revealed specific uptake at the sites of infection and clearance from vital organs. No uptake of tracer was observed in suspected infection foci in one patient, which was proven to be aseptic and served as negative control., Conclusion: This is the first report on 68 Ga labeled NOTA-UBI (31-38) fragment for prospective infection imaging., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Pharmaceutical grade DOTATOC kits compliant with all the quality control criteria were formulated and radiolabeled with 68 Ga in high yields. Comparison with module-based 68 Ga-DOTATOC established product equivalency. Clinical utility was evaluated in patients with histopathologically confirmed well-differentiated neuroendocrine tumors. Kit-based preparation of 68 Ga-DOTATOC could identify sites of primary and metastatic disease. PET/CT images of patients conformed to the established criteria for somatostatin imaging agents and clinical expectations. Results of this study emphasize the potential of kit-based 68 Ga-DOTATOC for PET imaging of neuroendocrine tumors., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Purpose: Somatostatin receptor positron emission tomography/X-ray computed tomography (SSTR-PET/CT) is a well-established technique for staging and detection of neuroendocrine tumors (NETs). Ga-68-labeled DOTA-conjugated octreotide analogs are the privileged radiotracers for diagnosis and therapeutic monitoring of NETs. Hence, we were interested in assessing the influence of promising, newer variant DOTAGA on the hydrophilicity, pharmacokinetics, and lesion pick-up of somatostatin analogs. Herein, the potential of ([ 68 Ga]DOTAGA, Tyr 3 , Thr 8 ) octreotide ([ 68 Ga]DOTAGA-TATE) and ([ 68 Ga]DOTAGA, Tyr 3 ) octreotide ([ 68 Ga]DOTAGA-TOC) as NET imaging agents has been investigated., Procedures: Amenability of [ 68 Ga]DOTAGA-(TATE/TOC) to kit-type formulation has been demonstrated. Biodistribution studies were carried out in normal rats at 1 h post-injection (p.i.). [ 68 Ga]DOTAGA-(TATE/TOC) PET/CT scans were carried out in patients (70-170 MBq, 1 h p.i.) with histologically confirmed well-differentiated NETs., Results: [ 68 Ga]DOTAGA-TATE exhibited hydrophilicity similar to [ 68 Ga]DOTA-TATE (log P = -3.51 vs -3.69) whereas [ 68 Ga]DOTAGA-TOC was more hydrophilic than [ 68 Ga]DOTA-TOC (log P = -3.27 vs -2.93). [ 68 Ga]DOTAGA-TATE and [ 68 Ga]DOTA-TATE showed almost identical blood and kidney uptake in normal rats whereas significantly fast clearance (p < 0.05) of [ 68 Ga]DOTAGA-TATE was observed from other non-specific organs (liver, lungs, spleen, intestine). [ 68 Ga]DOTAGA-TOC also demonstrated rapid clearance from blood and kidneys (p < 0.05) in comparison to [ 68 Ga]DOTA-TOC. The metastatic lesions in NET patients were well identified by [ 68 Ga]DOTAGA-TATE and [ 68 Ga]DOTAGA-TOC., Conclusion: The phenomenal analogy was observed between [ 68 Ga]DOTAGA-TATE and [ 68 Ga]DOTA-TATE as well as between [ 68 Ga]DOTAGA-TOC and [ 68 Ga]DOTA-TOC in biodistribution studies in rats. The good lesion detection ability of the two radiotracers indicates their potential as NET imaging radiotracers.

Purpose: The aim of this study was to evaluate the utility of Tc-ubiquicidin (Tc-UBI) (29-41) as an adjunct to an methylene diphosphonate (MDP) bone scan in differentiating septic versus aseptic loosening in patients with painful prosthesis posted for revision surgery., Patients and Methods: A two-vial cold kit of UBI (29-41) was prepared and utilized for the preparation of patient dose of Tc-UBI (29-41). Twenty two patients with painful hip or knee prosthesis and scheduled for revision surgery were included in the study. Overall, 370-555 MBq of Tc-UBI (29-41) was injected intravenously in all the patients. A blood pool image at 20 min after injection was followed by spot views of the suspected region of infection (target) and a corresponding normal area (nontarget) at 60 min. All patients underwent a routine Tc-MDP three-phase whole-body bone scan, followed by single-photon emission computed tomography/computed tomography of the prosthesis within a week of the Tc-UBI (29-41) study. For Tc-UBI scans, a visual score (0-3) was used to categorize studies as positive or negative, with scores of 0 (minimal or no uptake; less than soft tissue or contralateral extremity) and 1 (mild; equivalent to soft tissue or contralateral extremity) being considered negative and scores of 2 (moderate; uptake greater than soft tissue or contralateral extremity, but less than the liver) or 3 (intense; uptake greater than soft tissue or contralateral extremity and equivalent to the liver) being considered positive. The final correlation was on the basis of bacterial culture as the major criterion and the results of clinical tests, radiography, fluorine-18-fluorodeoxyglucose PET-CT, and three-phase bone scanning as the minor criteria., Results: In all, 22 studies were carried out with Tc-UBI (29-41). Of these, 16 scans were considered positive and six were negative for infection foci. All negative scans were subsequently confirmed to be true negative. Adverse reactions were not observed during image acquisition and within 5 days after the study. The overall sensitivity, specificity, and positive and negative predictive values were 100, 85.7, 93.75, and 100%, respectively. A combination of an MDP bone scan and UBI scans was considered to yield maximum confidence toward reporting for the presence of infection., Conclusion: Patient dose of Tc-UBI (29-41) was prepared successfully and a simple quality control method to check radiolabeling yield was used at the hospital radiopharmacy. Tc-UBI (29-41) showed promise in localizing foci of infection, with optimal visualization at 20-60 min, for the evaluation of prosthesis loosening.

Introduction: The commercially available 68 Ge/ 68 Ga generators are generally used in clinical context in conjunction with automated or semi-automated modules for the syntheses of 68 Ga radiopharmaceuticals. It is desirable to develop strategies for the formulation of 68 Ga-radiopharmaceuticals without use of such expensive modules in order to make 68 Ga-based clinical positron emission tomography (PET) more popular and affordable worldwide., Methods: An organic matrix based 68 Ge/ 68 Ga generator was used for preparation of clinically relevant doses of four different 68 Ga-based radiopharmaceuticals, namely 68 Ga-DOTA-NOC, 68 Ga-NODAGA-RGD 2 , 68 Ga-PSMA-11 and 68 Ga-BPAMD. Detailed performance evaluation of the generator was carried out over the period of 9months. The radiolabeling conditions were optimized in a hospital radiopharmacy directly utilizing 68 Ga eluted from the generator without use of any synthesis module. Quality control tests of the radiopharmaceuticals were carried out to assess their suitability for clinical use. The clinical utility of the synthesized radiopharmaceuticals was ascertained by performing PET scans in human patients., Results: During the period of evaluation, 68 Ga could be obtained from the generator in 4mL of 0.05M HCl with 60-85% elution yield and >99.99% radionuclidic purity. While directly using 68 Ga eluted from the generator, the 68 Ga-based radiopharmaceuticals could be prepared with >95% radiochemical purity and they met all the requirements for clinical administration. The clinical efficacy of the radiopharmaceuticals synthesized was established by PET scans in human patients. The performance of the generator remained consistent over the 9-month period and >100 clinical doses of different radiopharmaceuticals were prepared with excellent reproducibility and clinical effectiveness., Conclusions: The promising results obtained in this study would make 68 Ga-radiopharmacy more practical and cost effective in clinical context. To the best of our knowledge, this is the first report on the clinical scale syntheses and utilization of 68 Ga-based radiopharmaceuticals without using any synthesis module., (Copyright © 2016 Elsevier Inc. All rights reserved.)

We have earlier reported the potential of Tm-EDTMP as an alternative cost-effective radiopharmaceutical of SrCl2 for bone pain palliation application. Encouraging results obtained in the radiochemical studies and biological evaluations in animal model have prompted us to initiate the clinical study to evaluate the potential of Tm-EDTMP in human cancer patients. The serial scintigraphic images represent the whole-body scans of a patient (68 years old woman) with skeletal metastases of carcinoma of the breast origin recorded after administering 370 MBq (10 mCi) of Tm-EDTMP at different post-administration time points along with the pre-therapy images recorded with Tc-MDP in the same patient.

Purpose: [(68)Ga]DKFZ-PSMA-11 has proved to be an important diagnostic radiotracer for targeting prostate-specific membrane antigen (PSMA) overexpression in both recurrent prostate cancer (PC) and relevant metastatic sites. However, the widespread, routine clinical use of such a potential radiopharmaceutical demands availability of a ready-to-use kit formulation to enable convenient radiopharmaceutical preparation. Herein, we report the development of a freeze-dried kit vial for the formulation of [(68)Ga]DKFZ-PSMA-11 and its clinical use in patients using a "shake-bake-inject" methodology., Procedures: The freeze-dried kit vial was developed after optimization of ligand content (PSMA-11) and pH conditions. The kit was formulated using (68)Ga from two different commercially available generators. Positron emission tomography/X-ray computed tomography (PET/CT) images of PC patients were obtained using the kit-formulated radiotracer., Results: [(68)Ga]DKFZ-PSMA-11 was prepared in >98 % radiochemical yield and purity using the freeze-dried kit vials. Kits were optimized for the preparation of four patient doses. The clinical utility was evaluated in patients with histologically confirmed prostate cancer, and the images were of good quality as well as conforming to tumor marker and clinical expectations., Conclusion: The development of a simple and ready-to-use freeze-dried DKFZ-PSMA-11 kit for the preparation of Ga-68-based radiotracers constitutes a major step towards the expedition of the widespread and economical screening of PC patients.

Papillary and follicular thyroid carcinomas, together known as differentiated thyroid carcinomas (DTC), are among the most curable of cancers. Distant metastases are rare events at the onset of DTC. Among these presentations, metastasis to the liver is even more unusual. Only 11 cases of DTC with liver metastasis were previously reported in the literature. We present a 55-year-old male on Iodine-131 whole body scintigraphy showed intense uptake in thyroid bed, metastasis in both lungs and right lobe of the liver. Radioiodine concentration in liver metastases made him amenable to high-dose radioiodine therapy patient.

The aim of this study is to assess the effectiveness of Radiosynovectomy (RSV) using (177)Lu-labeled hydroxyapatite ((177)Lu-HA) in the treatment of painful synovitis and recurrent joint effusion of knee joints in rheumatoid arthritis (RA). Ten patients, diagnosed with RA and suffering from chronic painful resistant synovitis of the knee joints were referred for RSV. The joints were treated with 333 ± 46 MBq of (177)Lu-HA particles administered intra-articularly. Monitoring of activity distribution was performed by static imaging of knee joint and whole-body gamma imaging. The patients were evaluated clinically before RSV and at 6 months after the treatment by considering the pain improvement from baseline values in terms of a 100-point visual analog scale (VAS), the improvement of knee flexibility and the pain remission during the night. RSV response was classified as poor (VAS < 25), fair (VAS ≥ 25-50), good (VAS ≥ 50-75) and excellent (VAS ≥ 75), with excellent and good results considered to be success, while fair and poor as failure and also by range of motion. Three phase bone scan (BS) was repeated after 6 months and changes in the second phase of BS3 were assessed visually, using a four-degree scale and in the third phase, semiquantitatively with J/B ratio to see the response. Biochemical analysis of C-reactive protein (CRP) and fibrinogen was repeated after 48 h, 4 and 24 weeks. In all 10 patients, no leakage of administered activity to nontarget organs was visible in the whole-body scan. Static scans of the joint at 1 month revealed complete retention of (177)Lu-HA in the joints. All patients showed decreased joint swelling and pains, resulting in increased joint motion after 6 months. The percentage of VAS improvement from baseline values was 79.5 ± 20.0% 6 months after RS and found to be significantly related to patients' age (P = 0.01) and duration of the disease (P = 0.03). Knees with Steinbrocker's Grades 0 and I responded better than those with more advanced changes (Steinbrocker's Grades III and IV) in terms of VAS improvement (75% vs. 45.8%) (P < 0.001). The overall success rate (VAS ≥ 50) was 80%. Remission of pain during the night was achieved in 100%, and knee flexibility was improved in 80%. The changes in the blood pool phase before RSV were 3.2 ± 0.7 and after the therapy 1.4 ± 0.7 (P < 0.001). The J/B ratio was: Before RSV 2.4 ± 0.3; after treatment 1.0 ± 0.2 (P < 0.05). CRP concentration 4 and 24 weeks after the therapy was significantly lower than before treatment. The fibrinogen level was not different before and after RSV. RSV side-effects assessed for the whole follow-up period were minor and not significant. RSV with (177)Lu-HA was safe and effective in patients with knee joint chronic painful synovitis of rheumatoid origin. It exhibited significant therapeutic effect after 6 months follow-up period with no significant side-effects. The preliminary investigations reveal that (177)Lu-labeled HA particles hold considerable promise as a cost-effective agent for RSV. More elaborate and controlled clinical trials are necessary to evaluate the therapeutic efficacy and safety of the agent compared with the treatment with other radionuclides and glucocorticosteroids.

Several studies have reported on the expression of somatostatin receptors (SSTRs) in patients with differentiated thyroid cancer (DTC). The aim of this study was to evaluate the imaging abilities of a recently developed Technetium-99m labeled somatostatin analog, (99m)Tc-Hynic-TOC, in terms of precise localization of the disease. The study population consisted of 28 patients (16 men, 12 women; age range: 39-72 years) with histologically confirmed DTC, who presented with recurrent or persistent disease as indicated by elevated serum thyroglobulin (Tg) levels after initial treatment (serum Tg > 10 ng/ml off T4 suppression for 4-6 weeks). All patients were negative on the Iodine-131 posttherapy whole-body scans. Fluorine-18 fluorodeoxyglucose positron emission tomography ((18)F-FDG PET) was performed in all patients. SSTR scintigraphy was true positive in 23 cases (82.1%), true negative in two cases (7.1%) and false negative in three cases (10.7%) which resulted in a sensitivity of 88.46%, specificity of 100% and an accuracy of 89.2%. Sensitivity of (99m)Tc-Hynic-TOC scan was higher (93.7%) for patients with advanced stages, that is stages III and IV. (18)F-FDG showed a sensitivity of 93.7%, a specificity of 50% and an accuracy of 89.3%. (18)F-FDG PET was found to be more sensitive, with lower specificity due to false positive results in 2 patients. Analysis on a lesion basis demonstrated substantial agreement between the two imaging techniques with a Cohen's kappa of 0.66. Scintigraphy with (99m)Tc-Hynic-TOC might be a promising tool for treatment planning; it is easy to perform and showed sufficient accuracy for localization diagnostics in thyroid cancer patients with recurrent or metastatic disease.

A single vial freeze-dried kit formulation for preparation of three patients' dose of [(99m)Tc]TRODAT-1 has been developed for early diagnosis of Parkinson's disease (PD). Kits were evaluated to ascertain the purity, stability and batch to batch variations. Preclinical evaluation was carried out in laboratory animals and clinical imaging was performed in human patients with PD. The labeling yield and purity of [(99m)Tc]TRODAT-1 was >90%. Swiss mice showed retention of [(99m)Tc]TRODAT-1 in the mid brain region. Clinical studies showed decreased striatal uptake with increasing severity of PD., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by a selective loss of dopamine in the striatum. Problems remain in the accurate diagnosis of PD. The diagnosis of idiopathic PD is based on the interpretation of clinical signs and symptoms could be incorrect at the time of initial presentation. In vivo imaging of the dopaminergic system has the potential to improve the diagnosis of PD in its early stages. The imaging of dopamine transporter (DAT) with (99m)Tc-labeled tropane derivative (TRODAT-1) single photon emission computer tomography/computer tomography (SPECT/CT) has been proposed to be a valuable and feasible means of assessment of the integrity of dopamine neurons. The purpose of this study was to investigate the potential usefulness of (99m)Tc-TRODAT-1 imaging in the evaluation of patients with PD and classify into different stages of the disease. SPECT imaging with (99m)Tc-TRODAT-1 was conducted in 16 consecutive PD patients (9 men; 7 women) and in 6 age matched healthy volunteers (4 men; 2 women). The images were obtained 3 h after the intra-venous injection of the tracer. Specific uptake in the striatum and its sub-regions, including the putamen and caudate nucleus was calculated and the ratios of specific striatal binding to nonspecific occipital binding were calculated. ANOVA with Dunnett C post-hoc analysis was conducted using SPSS 20. A stepwise reduction in specific striatal uptake of (99m)Tc-TRODAT-1 with increasing disease severity between healthy control versus Stage I versus Stage II versus Stage III was found in PD patients (i.e., 3.77 vs. 2.56 vs. 1.57 vs. 0.63, P < 0.05). The changes were magnified by measurement of specific putaminal uptake (1.43 vs. 0.79 vs. 0.54 vs. 0.19, P < 0.05) and specific caudate uptake (1.90 vs. 1.47 vs. 0.73 vs. 0.27, P < 0.05). No remarkable adverse reactions were found in either healthy volunteers or PD patients during or after imaging. (99m)Tc-TRODAT-1 is accurate and widely available for the assessment of DAT activity, which might shed light on the integrity of the presynaptic nigrostriatal function. Our preliminary study results confirm the potential of using (99m)Tc-TRODAT-1 for DAT measurement, which is clinically important for the staging of PD.

While radiation synovectomy (RSV) constitutes a successful paradigm for the treatment of arthritis, a major cornerstone of its success resides in the selection of appropriate radiolabeled agent. Among the radionuclide used for RSV, the scope of using (177)Lu [T1/2  = 6.65 d, Eβ(max)  = 497 keV, Eγ  = 113 KeV (6.4%), 208 KeV (11%)] seemed to be attractive owing to its suitable decay characteristics, easy availability, and cost-effective production route. The present article describes a formulation of (177)Lu-labeled hydroxyapatite (HA) using ready-to-use kits of HA particles of 1-10 µm size range. The developed kits enable convenient one-step preparation of (177)Lu-HA (400 ± 30 MBq doses) in high radiochemical purity (>99%) and stability at hospital radiopharmacy. The preparation showed promising results in pre-clinical studies carried out in Wistar rats bearing arthritis in knee joints. In preliminary clinical investigation, significant improvement in the disease conditions was reported in 10 patients with rheumatoid arthritis of knee joints treated with 333 ± 46 MBq doses of (177)Lu-HA. The studies reveal that while (177)Lu labeled HA particles holds considerable promise as a cost-effective agent for RSV, the adopted strategy of using HA kits could be a potential step toward wider clinical utilization of radiolanthanide-labeled HA particles., (Copyright © 2014 John Wiley & Sons, Ltd.)

Unlabelled: (177)Lu-labeled ethylenediaminetetramethylene phosphonic acid ((177)Lu-EDTMP) is an agent that concentrates in areas of enhanced osteoblastic activity. The potential of (177)Lu-EDTMP for palliation of metastatic bone pain has been documented in the recent literature. The objective of the present work was to study the efficacy and safety of the agent after administration to a limited number of patients., Methods: Ten patients (median age, 68.5 y) with disseminated skeletal metastases received a single bolus infusion of (177)Lu-EDTMP (3.7 GBq). All patients had painful bone metastases in more than one anatomic region that were not relieved by narcotic analgesics. The efficacy of the agent was studied by following pain scores assessed at baseline and at 4, 8, and 12 wk after therapy, by using Karnofsky indices and mobility scores, and by determining the requirement for analgesics at baseline and 4 wk after therapy. The toxicity of the agent was assessed by analyzing complete blood counts., Results: A significant reduction in the mean pain score was noted in all patients. The initial mean pain score of 8.44 dropped to 5.73 within 1 mo of treatment. Six patients who required analgesics for pain management had either reduced or completely withdrawn from their use by 4 wk. Compared with initial scans, scans obtained 1 mo after therapy also showed a decreased uptake of the radiotracer. The mobility scores of all patients were higher at 4 wk. The mean Karnofsky performance score of all patients was initially 45 and increased markedly to 69 at 4 wk. None of the patients experienced blood-related toxicity., Conclusion: (177)Lu-EDTMP, with only low bone marrow toxicity, provided significant pain relief to patients and considerably increased their mobility, resulting in an overall improvement in the quality of life. The results of the preliminary clinical studies indicate that (177)Lu-EDTMP can be considered an effective and safe therapeutic radiopharmaceutical for pain palliation of patients with disseminated skeletal disease.