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Introduction: SPLASH (NCT04647526) is a multicenter phase III trial evaluating the efficacy and safety of [177Lu]Lu-PNT2002 radioligand therapy in metastatic castration-resistant prostate cancer (mCRPC). This study leveraged a lead-in phase to assess tissue dosimetry and evaluate preliminary safety and efficacy, prior to expansion into a randomized phase. Here we report those results. Methods: Enrolled participants had mCRPC that progressed on one prior androgen receptor pathway inhibitor (ARPI), were prostate-specific membrane antigen (PSMA) PET–positive as determined by a central reader, were chemotherapy-naïve for mCRPC, and had adequate bone marrow and end-organ reserve. Participants received up to 4 cycles of [177Lu]Lu-PNT2002 at 6.8 GBq (± 10%) intravenously per cycle every 8 weeks. Dosimetry (planar + SPECT/CT [n=7]; planar only [n=20]), safety, prostate-specific antigen (PSA) response, objective response rate (ORR), and radiographic progression-free survival (rPFS) per blinded independent central review were assessed. Results: Of 34 individuals screened, 32 underwent PSMA-PET/CT; 27 met all eligibility criteria. Median (range) age was 72 (57-86) years; all participants were enrolled in North America; 40.7% initiated prior ARPI treatment without distant metastases (M0) and 25.9% while hormone sensitive. Nineteen of 27 (70.4%) participants completed all 4 planned cycles. Organs receiving the largest mean (median, range) specific absorbed doses were lacrimal glands at 1.2 (0.9, 0.4-6.7) Gy/GBq (planar only [n=27]), followed by kidneys at 0.73 (0.63, 0.22-1.8) Gy/GBq (planar + SPECT/CT [n=7]; planar only [n=20]). Mean (median, range) tumor specific absorbed dose was 4.3 (2.1, 0.3-33.4) Gy/GBq (approximately 29 Gy/cycle) based on planar + SPECT/CT of 21 lesions in seven participants. [177Lu]Lu-PNT2002 was associated with no treatment-related deaths, few treatment-related grade ≥3 treatment-emergent adverse events (TEAEs), and no discontinuations for unacceptable toxicity. Treatment-related TEAEs occurring in ≥10% of participants included dry mouth (22.2%; all grade 1), fatigue (18.5%; grades 1-2), nausea (18.5%; grades 1-2), and anemia (14.8%; grades 1-3). Median (95% CI) rPFS was 11.5 (9.2-19.1) months, a PSA decline of ≥50% occurred in 42.3% (11/26) of participants, and confirmed ORR for evaluable disease was 50% (5/10). Conclusion: [177Lu]Lu-PNT2002, administered at 6.8 GBq/cycle for 4 cycles, demonstrated a favorable dosimetry and safety profile, as well as promising preliminary efficacy. Clinical trial registration: https://clinicaltrials.gov/ , identifier NCT04647526. [ABSTRACT FROM AUTHOR]

Biochemical recurrence (BCR) of prostate cancer (PCa) occurs in about 25% of patients treated with radical prostatectomy (RP) and up to 45% in patients who receive external beam radiotherapy (RT). Early diagnosis of PCa recurrence is of high importance for successful salvage therapy. The aim of the present study is to analyze the efficacy of 68 Ga-PSMA PET/CT in detecting the presence of local and/or systemic disease in patients with a history of PCa who have BCR. A total of 52 PCa patients with BCR referred for 68 Ga-PSMA PET/CT were recruited from the American University of Beirut Medical Center between November 2017 and December 2019. We compared the performance of PSMA PET/CT to the results and clinical factors based on follow up: PSA, PSA kinetics, primary treatment, and Gleason score. The relationship between the PET/CT findings and clinical indicators of disease were assessed by univariate and multivariate logistic regression. From a total of 52 patients, 34 (65.4%) had positive PSMA-PET/CT scans. Among those, 8/34 (23.5%) received primary RT. For all patients with a positive PSMA-PET: the detection rate was 2/4 (50%) for PSA < 0.2, 5/10 (50%) for PSA 0.2–0.49, 3/6 (50%) for PSA 0.5–0.99, 6/12 (50%) for PSA 1–1.99, 8/9 (88.9%) for PSA 2–3.99, and 10/11 (90.9%) for PSA 4–10. PSMA-PET/CT positivity was significantly associated with PSA level at time of PET scan, PSA doubling time, Gleason score and TNM staging. However, it did not show a significant correlation with radiotherapy as primary treatment, ongoing androgen deprivation therapy (ADT), time to relapse, and initial PSA before therapy. In our single center prospective trial, 68 Ga-PSMA PET/CT successfully detected the recurrence of PCa in patients with BCR. Scan positivity was significantly associated with PSA level at time of PET scan, PSA doubling time, Gleason score, and TNM staging. PSMA- PET/CT is a highly promising modality in the work up of patients with PCa in the setting of BCR for earlier detection of disease recurrence. [ABSTRACT FROM AUTHOR]

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Abstract Introduction Breast lymphoma accounts for less than 1% of all non-Hodgkin's lymphomas and approximately 0.1% of all breast neoplasms. Most breast lymphomas are classified as diffuse large B-cell lymphomas or as mucosa associated lymphoid tissue lymphomas. Concurrent cases of breast lymphoma and cervical cancer are extremely rare. Case presentation We report a case of a 46-year-old woman of unknown ethnic origin diagnosed with concurrent diffuse large B-cell lymphoma of the breast and squamous cell cancer of the cervix that was detected and followed with F-18 fluorodeoxyglucose (FDG) positron emission tomography and/or computed tomography (PET/CT). The metastatic pattern of this case of breast lymphoma is similar to that of a typical metastatic breast carcinoma. These findings have never been described in the literature. PET/CT also demonstrated an incidentally intense FDG focus in the uterine cervix ultimately leading to the pathologic diagnosis of squamous cell carcinoma of the uterine cervix. An appropriate staging of breast lymphoma and cervical cancer with FDG PET/CT is important because of therapeutic consequence. This case report and review of the literature highlights the role of FDG PET/CT in staging and restaging of both breast lymphoma and cervical cancer. Conclusions We report a case of a breast lymphoma with a metastatic pattern similar to that of typical metastatic breast carcinoma. The FDG PET/CT scan also diagnosed a rare case of concurrent breast lymphoma and cervical cancer. This concurrence has not been reported previously in the medical literature.

Abstract Background The aim of this retrospective study was to report the prevalence and patterns of soft tissue (ST) metastasis detected with true whole-body (TWB) F-18 FDG PET/CT acquired from the top of the skull through the bottom of the feet and to compare such findings to that of the typically acquired skull-base to upper-thigh, thus limited whole-body (LWB) field of view (FOV). Methods TWB FDG-PET/CT scans were performed in 500 consecutive cancer patients. Suspected ST metastasis was verified by correlation with surgical pathology, other imaging modalities, or clinical follow-up. Results Nine out of 500 patients (1.8 %) had ST metastasis with a prevalence of 4/41 (9.8%) for melanoma, 2/60 (3.3%) for lung carcinoma, 2/88 (2.3%) for lymphoma and 1/13 (77%) for esophageal cancer. Those nine patients had a total of 41 ST lesions: 22 lesions within and 19 outside of LWB FOV. Of those 41 lesions, 19 (46%) were subcutaneous and 22 (54%) were muscular lesions. The presence of ST metastasis neither changed the staging nor the treatment in any of these patients. However, the ST lesions provided a biopsy site in 4 of the 9 patients (44%). Seven out of nine studied patients died of their disease within 1–22 months after ST metastasis was diagnosed. Conclusion The detection of ST metastasis may have prognostic implications, provide more accessible biopsy sites and help avoid invasive procedures. A LWB scanning may underestimate the true extent of ST metastasis since a significant percentage of ST metastasis (46%) occurred outside the typical LWB FOV.

Quality control in a nuclear medicine department plays an important role in providing quality care for patients. Closely monitoring the uniformity values on extrinsic quality control can give insight into problems outside typical equipment issues. This facility noticed increasing uniformity values along with a photopenic image artifact. The detector required photocoupling gel replacement and a full rebuild by service engineers. This process required time for the rebuild and time for the gel to set. Another adjustment of the voltage to the photomultiplier tubes (PMTs) was required due to photocathode excitation in every cathode in every PMT in that detector. After the detector was rebuilt, the voltage was retuned with the field service engineers' knowledge that the PMTs would need to be retuned due to this excitation. Communication and understanding of equipment problems in aging γ-cameras can lead to proper equipment use and better quality in nuclear medicine departments. [ABSTRACT FROM AUTHOR]

Pediatric nasopharyngeal carcinoma is a rare malignancy strongly associated with Epstein-Barr virus infection. Patients typically present with non-specific symptoms of epistaxis or serous otitis from eustachian tube obstruction and therefore diagnosis is often delayed. We present a case of a previously healthy 17 year old female who initially complained of migraines which was resistant to oral medication. Symptoms progressed and she saw a dental surgeon for concern of a dental infection and was prescribed antibiotics with no relief. Her symptoms continued to progress until an otolaryngologist visualized a large mass along the floor of the left nasal cavity. Subsequent imaging showed a large mass in the posterior left nasal cavity and biopsy was consistent with nasopharyngeal carcinoma. [ABSTRACT FROM AUTHOR]

A novel quality control and quality assurance device provides time-activity curves that can identify and characterize PET/CT radiotracer infiltration at the injection site during the uptake phase. The purpose of this study was to compare rates of infiltration detected by the device with rates detected by physicians. We also assessed the value of using the device to improve injection results in our center. Methods: 109 subjects consented to the study. All had passive device sensors applied to their skin near the injection site and mirrored on the contralateral arm during the entire uptake period. Nuclear medicine physicians reviewed standard images for the presence of dose infiltration. Sensor-generated time-activity curves were independently examined and then compared with the physician reports. Injection data captured by the software were analyzed, and the results were provided to the technologists. Improvement measures were implemented, and rates were remeasured. Results: Physician review of the initial 40 head-to-toe field-of-view images identified 15 cases (38%) of dose infiltration (9 minor, 5 moderate, and 1 significant). Sensor time-activity curves on these 40 cases independently identified 22 cases (55%) of dose infiltration (16 minor, 5 moderate, and 1 significant). After the time-activity curve results and the contributing factor analysis were shared with technologists, injection techniques were modified and an additional 69 cases were studied. Of these, physician review identified 17 cases (25%) of infiltration (13 minor, 3 moderate, and 1 significant), a 34% decline. Sensor time-activity curves identified 4 cases (6%) of infiltration (2 minor and 2 moderate), an 89% decline. Conclusion: The device provides valuable quality control information for each subject. Time-activity curves can further characterize visible infiltration. Even when the injection site was out of the field of view, the time-activity curves could still detect and characterize infiltration. Our initial experience showed that the quality assurance information obtained from the device helped reduce the rate and severity of infiltration. The device revealed site-specific contributing factors that helped nuclear medicine physicians and technologists customize their quality improvement efforts to these site-specific issues. Reducing infiltration can improve image quality and SUV quantification, as well as the ability to minimize variability in a site's PET/CT results. [ABSTRACT FROM AUTHOR]

Myocardial perfusion SPECT plays a crucial role in the diagnosis of coronary artery disease, providing a noninvasive tool to monitor ischemia and infarction. The findings can have a profound impact on diagnosis and management in these patients. However, incidental noncardiac findings on myocardial perfusion SPECT images can also affect management. These noncardiac subtleties are most often detected on the rotating raw SPECT images, which are often overlooked. The intent of this pictorial essay is to illustrate several subtle noncardiac abnormalities within nuclear cardiac imaging that can have an impact on patient management and follow-up. [ABSTRACT FROM AUTHOR]

Objective: The current guidelines for 2-deoxy-2-[18F]fluoro-d-glucose PET/CT scanning do not address potential inaccuracies that may arise due to patients with renal failure. We report a retrospective analysis of standard uptake values (SUVs) in patients with and without renal failure in order to warrant a protocol adjustment. Methods: Patients were matched based on age, gender, and BMI all of which are potential effectors on observed SUV. Thirty patients were selected with clinically diagnosed renal failure, of which 12 were on dialysis. All 30 patients had age, gender, and BMI control matches. Blood urea nitrogen and creatinine levels were measured within 1 month of the scan to assess renal failure. PET/CT scans for both the renal failure patients and controls were performed 60 min after FDG injection. SUVs were measured by placing circular regions of interest in the right hepatic lobe (LSUV) and left psoas muscle (PSUV). Results: For the 30 renal failure patients, the mean LSUV was 2.77 (SD = 0.57) and PSUV was 1.43 (SD = 0.30) while the controls had mean LSUV 2.74 (SD = 0.50) and PSUV 1.42 (SD = 0.37). The SUVs from both the liver and psoas muscle were not significantly different between the renal failure patients and the normal controls with p values >0.05. In addition, dialysis and gender also had no effect on SUVs. Conclusion: Our data suggest that renal failure patients do not require an adjustment in protocol and the standard protocol times should remain. [ABSTRACT FROM AUTHOR]

Objectives: The aim of our study is to assess the frequency of detection of PET-positive computed tomography (CT)-negative skeletal metastases (SM) and determine the impact of such detection on staging and/or management in patients who had FDG PET/ CT as part of the cancer work-up. Methods: We retrospectively reviewed 2000 18F-FDG PET/CT scans of known cancer patients. A log was kept to record cases of suspected SM with or without bone changes from the low-dose non-contrast CT. The presence or absence of SM was evaluated based on available pathological and clinical data. The impact of detection of such lesions on cancer staging and/or management was evaluated by a board certified oncologist. Results: Of the 2000 cases, 18F-FDG PET/CT suggested SM in 146/2000 (7.3%). Of those 146 cases, 105 (72%) were positive on both PET and CT. The remaining 41 (28%) had PET-positive CT-negative bone lesions. SM was confirmed in 36/41 (88%) PET-positive/ CT-negative cases. This was based on biopsy, imaging, or clinical follow-up. The detection of PET-positive CT-negative SM did not change staging or management in 7/36 (19.4%). However, staging and/or management was affected in 29/36 (80.6%). Conclusion: SM is not uncommon in 18F-FDG PET/CT, as it accounts for 146/2000 (7.3%) of cases. PET demonstrated FDG-avid SM without a CT abnormality in at least 36/146 (25%). Patients staging and/or management changed in 29/36 (80.5%). We concluded that 18F-FDG PET is sensitive in the detection of SM with significant impact on staging and/or management. [ABSTRACT FROM AUTHOR]

AIMS: The prognosis of nonsmall cell lung cancer with cavitation (NSCLC-c) is not well-known. We compared the positron emission tomography/computed tomography (PET/CT) findings and survival data of patients with NSCLC-c patients with those without cavitation (NSCLC-nc). METHODS: Between 7/2004 and 6/2007, cavitary lung lesions were identified in 46/248 patients undergoing fluorodeoxyglucose (FDG) PET/CT for lung nodule characterization or lung cancer staging. Within the same period, 40 of 202 patients with NSCLC-nc were randomly selected for comparison. The primary was assessed by location, size, cell type, and standardized uptake value (SUV). Disease stage was determined according to American Joint Committee on Cancer guidelines for lung cancer. Kaplan–Meier method was used for survival analysis and Cox regression to assess the effect of clinical and imaging variables on survival. RESULTS: NSCLC-c was found in 87% of patients that had a cavitary lung lesion at PET/CT. Squamous cell carcinoma, primary size and primary-to-liver SUV ratio differed significantly between NSCLC-c and NSCLC-nc, whereas age, gender, primary location, primary SUV, type of treatment, and disease stage did not. Median survival and overall 5-year survival were 19 months and 24% for NSCLC-c, and 31 months and 31% for NSCLC-nc, P = 0.23. Disease stage was the only predictor of survival. CONCLUSION: Cavitary lung lesions in patients undergoing FDG PET/CT harbor a significant risk for cancer. NSCLC-c is associated with squamous cell carcinoma, larger size, and greater FDG metabolism compared with NSCLC-nc, although these variables may not be predictive of survival. Nonetheless, PET/CT contributes to accurate staging and has an indirect impact on prognosis. [ABSTRACT FROM AUTHOR]

Objective: To determine whether FDG PET/CT was more sensitive than CT in detecting metastatic disease in the cardiophrenic space and whether the presence of disease in this location would change the staging and clinical management. Materials and Methods: About 1200 PET/CT scans were retrospectively reviewed over 20 months for the presence of FDG-avid cardiophrenic lymph nodes. The SUVmax was used to quantify the metabolic activity in each of the lymph nodes. The radiographic data was used for correlation. A retrospective review of diagnostic CT reports performed within a 1-month period of time of the PET/CT in the same subset of patients determined whether cardiophrenic lymph nodes were mentioned. Results: About 9 (0.8%) of the 1200 studies were found to have FDG-avid cardiophrenic lymph nodes (four males and five females with a mean age of 55 years; range 7-69, median 59).The mean SUVmax was 2.4 (range 1.2-7.9; median 1.9). Only three of the patients were found to have suspicious lymph nodes on CT. The presence of cardiophrenic lymph nodes had the potential to change the staging and/or management in three of the patients. Conclusion: PET/CT is more accurate in the detection of pathologic cardiophrenic lymph nodes than CT, especially when they are subcentimeter in size. When present, staging and/or management was potentially affected in 33%. Therefore, these nodes should be included in theTNM staging classification. [ABSTRACT FROM AUTHOR]

Objectives/Hypothesis The role of follow-up and the detection of recurrent or new primary disease in cancer management remains to be defined. Specifically, the effectiveness and impact on survival of imaging studies that detects disease before it is symptomatic or noted on exam is unknown. Study Design Retrospective chart review. Methods A retrospective review was performed on a series of head and neck cancer patients (n = 123), at a single institution from February 18, 2004 to July 9, 2007, who had undergone nonstaging 18F-fluorodeoxyglucose positron emission tomography-computing tomography ( FDG PET-CT) scans as an integral part of the patient's follow-up after definitive treatment. Each scan (n = 308) was evaluated by a board-certified nuclear medicine physician, and final scan readings from each patient's medical record were reviewed for this study. Results Of the 123 patients in the study, 24 (20%) were noted to have asymptomatic lesions (either recurrent or new primaries) indicated on PET/CT (8% of surveillance scans) at an average interval of 35.7 weeks posttreatment. Asymptomatic lesions were detected most frequently at distant sites, with 50% being thoracic, but also included were primary (9%), regional (9%), and other distant (32%) sites. At last follow-up of the 24 patients in whom an asymptomatic lesion was detected, 14 patients have died of disease; 10 patients remain alive, four with disease; and one patient had a subsequent recurrence treated and is currently disease-free. Conclusion PET-CT scanning is an effective tool for detecting asymptomatic disease in patients previously treated for head and neck cancer. Unfortunately, even with early detection of recurrent disease, the mortality rate remains high. Level of Evidence 2B. Laryngoscope, 123:2161-2164, 2013 [ABSTRACT FROM AUTHOR]

Purpose: To assess the value of extending the routinely used base-of-skull (BOS) to upper-thigh field of view (FOV) to include the head on 18F-FDG PET/CT in cancer patients. Methods: We retrospectively reviewed 1000 consecutive top-of-head to foot PET/CT studies. Abnormalities above BOS were categorized as unsuspected or known and were correlated with pathology, MRI/CT, and clinical follow-up. Results: Of the 1000 patients, 102 (10.2%) had potentially significant findings above BOS. Of these, 70/102 (69%) were known and 32/102 (31%) were unsuspected. Of the patients with unsuspected findings, follow-up data was unavailable in 7/32 (22%) and abnormalities were confirmed in 25/32 (78%). Of the 25 confirmed unsuspected findings, 4/25 (16%) were false positives and 21/25 (84%) were true positives. Of these, 13/21 (62%) were confirmed metastatic, and 8/21 (38%) were benign. Unsuspected finding of brain metastasis changed the management in 11/13 (85%) and staging in 4/13 (31%). Conclusion: Including the head in PET/CT FOV incidentally detected clinically significant findings in 2.1% (21/1000) of patients. The detection of previously unsuspected metastasis had significant impact on patient management and provided more accurate staging. [ABSTRACT FROM AUTHOR]

Purpose. We retrospectively compared the maximum standard uptake value (SUVmax) of FDG PET in four different sites to evaluate whether a common diagnostic SUVmax threshold may exist in these tumor locations. We further postulate that the SUVmax thresholds are higher in thoracic lesions than in extrathoracic lesions. Material and methods. N == 143 patients in four subgroups underwent a FDG PET/CT: a) 42 patients for solitary pulmonary nodules (SPNs) characterization with b) respective mediastinal lymph nodes (LNs), c) 65 patients for LN staging of head and neck cancer, and d) 36 cancer patients diagnosed with adrenal lesions. Receiver operating characteristics of SUVmax values were evaluated. Results. The SUVmax were statistically significantly greater in malignant than in benign lesions. For SPNs and mediastinal LNs, a SUVmax > 3.6 each resulted in a sensitivity of 81% and 87%, and a specificity of 94% and 89%. For cervical LNs and adrenal glands, a SUVmax > 2.2 each showed a sensitivity of 98% and 100%, and a specificity of 83% and 93%. Conclusion. A common SUVmax threshold did not exist in the four studied subgroups. The variable FDG uptake in SPNs and mediastinal LNs are associated with the high prevalence of inflammation/infection within the chest. Similar SUVmax thresholds however may exist for extrathoracic regions where the prevalence of inflammation/infection is low. [ABSTRACT FROM AUTHOR]

Background: The aim of this retrospective study was to report the prevalence and patterns of soft tissue (ST) metastasis detected with true whole-body (TWB) F-18 FDG PET/CT acquired from the top of the skull through the bottom of the feet and to compare such findings to that of the typically acquired skull-base to upper-thigh, thus limited whole-body (LWB) field of view (FOV). Methods: TWB FDG-PET/CT scans were performed in 500 consecutive cancer patients. Suspected ST metastasis was verified by correlation with surgical pathology, other imaging modalities, or clinical follow-up. Results: Nine out of 500 patients (1.8 %) had ST metastasis with a prevalence of 4/41 (9.8%) for melanoma, 2/60 (3.3%) for lung carcinoma, 2/88 (2.3%) for lymphoma and 1/13 (77%) for esophageal cancer. Those nine patients had a total of 41 ST lesions: 22 lesions within and 19 outside of LWB FOV. Of those 41 lesions, 19 (46%) were subcutaneous and 22 (54%) were muscular lesions. The presence of ST metastasis neither changed the staging nor the treatment in any of these patients. However, the ST lesions provided a biopsy site in 4 of the 9 patients (44%). Seven out of nine studied patients died of their disease within 1-22 months after ST metastasis was diagnosed. Conclusion: The detection of ST metastasis may have prognostic implications, provide more accessible biopsy sites and help avoid invasive procedures. A LWB scanning may underestimate the true extent of ST metastasis since a significant percentage of ST metastasis (46%) occurred outside the typical LWB FOV. [ABSTRACT FROM AUTHOR]

Evaluates for possible respiratory motion artifacts (RMA) in positron emission tomography (PET) images attenuation corrected with CD from PET-CT in clinical patients. Performance of PET-CT scans using a Discovery LS PET-CT system; Artificats originating from the use of CT data for attenuation correction.

Sjögren syndrome (SS) is an autoimmune disease with exocrine glands dysfunction and multiorgan involvement. It is associated with increased risk of lymphoproliferative disorders, especially B-cell marginal zone lymphoma. While the role of F-18 Fluorodeoxyglucose position emission tomography/computed tomography (F-18 FDG PET/CT) for evaluation of lymphoma has been established, its use in patients with a chronic history of SS to evaluate for possible lymphoproliferative disorders or multiorgan involvement is limited. We present a case of chronic SS in which F-18 FDG PET/CT demonstrated FDG avid intraparotid and cervical lymph nodes pathologically proven to be mucosa-associated lymphoid tissue lymphoma. In addition, the patient had bibasilar cystic changes consistent with lymphocytic interstitial pneumonia. [ABSTRACT FROM AUTHOR]