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This version of the guideline for radioiodine therapy of benign thyroid disorders is an update of the version, which was published by the German Society of Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) in co-ordination with the German Society of Endocrinology (Deutsche Gesellschaft für Endokrinologie, DGE, Sektion Schilddrüse) and the German Society of General- and Visceral-Surgery (Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie, DGAV) in 2015. This guideline was harmonized with the recommendations of the European Association of Nuclear Medicine (EANM). According to the German "Directive on Radiation Protection in Medicine" the physician specialised in nuclear medicine ("Fachkunde in der Therapie mit offenen radioaktiven Stoffen") is responsible for the justification to treat with radioiodine. Therefore, relevant medical indications for radioiodine therapy and alternative therapeutic options are discussed within the guideline. This procedure guideline is developed in the consensus of an expert group. This fulfils the level S1 (first step) within the German classification of Clinical Practice Guidelines., Competing Interests: Erklärung zu finanziellen InteressenForschungsförderung erhalten: nein; Honorar/geldwerten Vorteil für Referententätigkeit erhalten: nein; Bezahlter Berater/interner Schulungsreferent/Gehaltsempfänger: nein; Patent/Geschäftsanteile/Aktien (Autor/Partner, Ehepartner, Kinder) an Firma (Sponsor der Veranstaltung): nein; Patent/Geschäftsanteile/Aktien (Autor/Partner, Ehepartner, Kinder) an Firma (Nicht-Sponsor der Veranstaltung): nein.Erklärung zu nichtfinanziellen InteressenDie Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

The interdisciplinary possibilities inherent in nuclear medicine offer an opportunity for the patient-centered development of radioactive pharmaceuticals based on specific research questions. This approach provides radiopharmaceutical manufacturers with a robust scientific foundation on which to navigate the regulatory requirements for drug approval laid down by the law. A vivid illustration of this interdisciplinary cooperation has been the development of a Zr-89-labeled PSMA ligand where reliable results have been obtained across various domains, including chemistry, radiochemistry, biochemistry, and preclinical research. This comprehensive process extended to feasibility studies conducted with carefully selected patients from a single nuclear medicine clinic. The approach demonstrates how far close collaboration between different disciplines within nuclear medicine can further the move towards patient-oriented radiopharmaceutical treatments while simultaneously meeting regulatory demands. With such a strategy, innovative radiopharmaceutical solutions can be brought to the market more swiftly and efficiently, in line with the needs of patients., Competing Interests: The authors declare no conflicts of interest.

A consensus statement about indications for post-surgical radioiodine therapy (RIT) in differentiated thyroid cancer patients (DTC) was recently published by the European Thyroid Association (ETA) 1. This publication discusses indications for RIT on the basis of an individual risk assessment. Many of the conclusions of this consensus statement are well founded and accepted across the disciplines involved. However, especially from the perspective of nuclear medicine, as the discipline responsible for indicating and executing RIT, some of the recommendations may require further clarification with regard to their compatibility with established best practice and national standards of care. Assessment of the indications for RIT is strongly dependent on the weighing up of benefits and risks. On the basis of longstanding clinical experience in nuclear medicine, RIT represents a highly specific precision medicine procedure of proven efficacy with a favorable side-effect profile. This distinguishes RIT significantly from other adjuvant oncological therapies and has resulted in the establishment of this procedure as a usually well-tolerated, standard safety measure. With regard to its favorable risk/benefit ratio, this procedure should not be unnecessarily restricted, in the interest of offering reassurance to the patients. Both patients' interests and regional/national differences need to be taken into account. We would therefore like to comment on the recent consensus from the perspective of authors and to provide recommendations based on the respective published data., Competing Interests: Alexander Drzezga:Research support: Siemens Healthineers, Life Molecular Imaging, GE Healthcare, AVID Radiopharmaceuticals, SOFIE, EisaiSpeaker Honorary/Advisory Boards: Siemens Healthineers, Sanofi, GE Healthcare, Biogen, Novo Nordisk, Invicro, Novartis/AAAStock: Siemens Healthineers, Lantheus HoldingPatents: Patent pending for 18F-PSMA7 (PSMA PET imaging tracer).Ken Herrmann:Personal fees from Bayer, personal fees and other from Sofie Biosciences, personal fees from SIRTEX, non-financial support from ABX, personal fees from Adacap, personal fees from Curium, personal fees from Endocyte, grants and personal fees from BTG, personal fees from IPSEN, personal fees from Siemens Healthineers, personal fees from GE Healthcare, personal fees from Amgen, personal fees from Novartis, personal fees from ymabs, personal fees from Aktis Oncology, personal fees from Theragnostics, personal fees from Pharma15, outside the submitted work., (Thieme. All rights reserved.)

The version 5 of the guideline for radioiodine therapy of benign thyroid disorders is an update of the version 4, which was published by the German Society of Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) in co-ordination with the German Society of Endocrinology (Deutsche Gesellschaft für Endokrinologie, DGE, Sektion Schilddrüse) and the German Society of General- and Visceral-Surgery (Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie, DGAV) in 2007. This guideline was harmonized with the recommendations of the European Association of Nuclear Medicine (EANM). According to the German "Directive on Radiation Protection in Medicine" the physician specialised in nuclear medicine ("Fachkunde in der Therapie mit offenen radioaktiven Stoffen") is responsible for the justfication to treat with radioiodine. Therefore, relevant medical indications for radioiodine therapy and alternative therapeutic options are discussed within the guideline. This procedure guideline is developed in the consensus of a representative expert group. This fulfils the level S1 (first step) within the German classification of Clinical Practice Guidelines.

The procedure guideline for radioiodine therapy of differentiated thyroid cancer (version 4) was developed in the consensus of a representative expert group. This fulfils the level S1 (first step) within the AWMF classification of Clinical Practice Guidelines (AWMF, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, Germany). This procedure guideline completed the guideline for surgical management of thyroid cancer (level S2) with the aspects from nuclear medicine. Controversies over ablative radioiodine therapy in small papillary thyroid cancers and in minimally invasive follicular cancer without angioinvasion, over empirical standard doses for ablative radioiodine therapy, and over the kind of TSH-stimulation were described and the guideline formulated a corridor of good clinical practice. The text has included the recent results from the National Cancer database and the SEER database (both from the USA), indicating that the ablative radioiodine therapy has improved the survival rate even in low risk patients. Such a statistically significant benefit can be detected only by a national cancer registry with long-term follow-up data.

The purpose of the present guidelines on the (131)I therapy of benign thyroid disorders formulated by the European Association of Nuclear Medicine (EANM) Therapy Committee is to provide advice to nuclear medicine clinicians on how to treat benign thyroid conditions employing optimal (131)I activities. The recommendations were formulated based on recent literature and expert opinion regarding rationale, indications and contraindications for the use of (131)I procedures, as well as the adequate (131)I activities in different thyroid disorders, and the administration and patient preparation techniques to be used. Recommendations are also provided on history and examinations before (131)I therapy, patient counselling and precautions associated with (131)I therapy. Furthermore, potential side effects and alternative treatment modalities are reviewed. Special attention is paid to these aspects in the treatment of children undergoing this procedure.

Unlabelled: All public licensed hospitals of Germany are obligated since 2004 to establish and to publish a structured biennial quality report. The aim of this study was to analyse the quality reports from 2008 of clinics with nuclear-medicine therapy ward and to investigate developments for the inpatient nuclear-medicine therapy by comparing the results with the quality reports of the years 2004 and 2006., Methods: All available structured quality reports of clinics with a nuclear-medicine therapy ward of the years 2004, 2006 and 2008 were evaluated., Results: The total number of inpatient treatment cases in 2008 amounted to 54190 (2006: 54884; 2004: 57366). This corresponds to a decrease of 5.5% in comparison to 2004. The number of the therapy wards decreased at the same time to currently 117 (2006: 120; 2004: 124). Remarkable changes were found in the spectrum of the main diagnosis. Thus, the most frequent diagnosis with the ICD-code E05 (hyperthyroidism) decreased continuously from 37747 treatments in 2004 and 34764 in 2006 to 31756 in the year 2008. In contrast, the ICD-diagnoses for thyroid cancer (C73, Z08) with 14761 cases in 2008 increased with time (2006: 13426; 2004: 12581)., Conclusions: In analogy to the observations from Europe after introduction of an iodine prophylaxis the improved iodine supply in Germany has led to a decline of the radioiodine therapy due to hyperthyroidism.

The German Society of Nuclear Medicine (DGN) criticizes the methodological approach of the IQWiG for evaluation of PET and the conclusions, which represent the opposite point of view compared to the most other European countries and health companies in the USA: 1.) Real integration of experienced physicians into the interpretation of data and the evaluation of effectiveness should be used for best possible reporting instead of only formal hearing. 2.) Data of the National Oncologic PET Registry (NOPR) from the USA have shown, that PET has changed the therapeutic management in 38% of patients. 3.) The decision of the IQWiG to accept outcome data only for their benefit analyses, is controversial. Medical knowledge is generated by different methods, and an actual analysis of the scientific guidelines has shown that only 15 % out of all guidelines are based on the level of evidence demanded by the IQWiG. Health economics has created different assessment methods for the evaluation of a diagnostic procedure. The strategy chosen by the IQWiG overestimated the perspective of the population and undervalue the benefit for an individual patient. 4.) PET evaluates the effectiveness of a therapeutic procedure, but does not create an effective therapy. When the predictive value of PET is already implemented in a specific study design and the result of PET define a specific management, the trial evaluate the whole algorithm and PET is part of this algorithm only. When PET is implemented as test during chemotherapy or by the end of chemotherapy, the predictive value of PET will depend decisively on the effectiveness of the therapy: The better the therapy, the smaller the differences in survival detected by PET. 5.) The significance of an optimal staging by the integration of PET will increase. Rationale is the actual development of "titration" of chemotherapy intensity and radiation dose towards the lowest possible, just about effective dosage. 6.) The medical therapy of malignancies will be improved continuously. It is the claim of the health insurances to implement innovative therapeutic approaches in controlled clinical trials with tools of quality control. The monitoring committee is responsible for the safety of the patients. PET is part of the health care. Internationally accepted rules for clinical trials stipulate that any interim analyses of those trials are confidential as long as recruitment is active. The delay until evidence is documented by the published final analysis is methodologically accepted and not a characteristic of PET. 7.) Procedures in nuclear medicine without the use of PET-tracers with short half-life will increase the radiation exposure of the patients; the use of non-PET-tracers with longer half-life is in contravention of the German regulation of radiation protection.

Introduction: The purpose of the present guidelines on the radioiodine therapy (RAIT) of differentiated thyroid cancer (DTC) formulated by the European Association of Nuclear Medicine (EANM) Therapy Committee is to provide advice to nuclear medicine clinicians and other members of the DTC-treating community on how to ablate thyroid remnant or treat inoperable advanced DTC or both employing large 131-iodine ((131)I) activities., Discussion: For this purpose, recommendations have been formulated based on recent literature and expert opinion regarding the rationale, indications and contraindications for these procedures, as well as the radioiodine activities and the administration and patient preparation techniques to be used. Recommendations also are provided on pre-RAIT history and examinations, patient counselling and precautions that should be associated with (131)I iodine ablation and treatment. Furthermore, potential side effects of radioiodine therapy and alternate or additional treatments to this modality are reviewed. Appendices furnish information on dosimetry and post-therapy scintigraphy.

This overview presents the indications of tumour SPECT in contrast to tumour PET using (18)F-FDG. A number of diagnostic SPECT radiopharmaceuticals have been used for years in oncology and are widely available in nuclear medicine departments. Today, tumour SPECT has to compete with tumour PET using (18)F-FDG. Other PET radiopharmaceuticals are common only in specialised centers. In comparison to SPECT, PET images with their higher resolution are technically superior. Therefore, PET is better than SPECT in localising a tumour, if the special tumour entity accumulates (18)F-FDG. Thus, (18)F-FDG-PET has largely replaced SPECT examinations using (201)Tl chloride, (67)Ga citrate or (99m)Tc anti-CEA. It is questionable whether mammascintigraphy using (99m)Tc-MIBI or (99m)Tctetrofosmine will be broadly accepted in clinical routine. SPECT radiopharmaceuticals are still up to date for examination of tumour entities which do not accumulate (18)F-FDG (e. g. neuroendocrine tumours) and in clinical problem solving if (18)F-FDG-PET is not regarded as superior (e. g. search for recurrent medullary thyroid carcinoma) or in the management of tumours with overlapping diagnosis and therapy as it is the case for differentiated thyroid carcinomas ((123)I/(131)I-NaI), phaeochromozytomas, and neuroblastomas ((123)I/(131)I-MIBG), carcinoids, gastroenteropancreatic tumours, paragangliomas, and Merkel-cell tumours (somatostatin receptor scintigraphy). Future developments concerning new SPECT radiopharmaceuticals and image fusion such as SPECT/CT are expected.

The guidelines for publishing economic evaluations require a statement of the economic importance of the analysis and the viewpoint from which it has been carried out, as well as specification of at least two alternative programmes or interventions, the form of economic evaluation, the outcome measure, the method of costing, the time horizon and adjustment for timing of costs and benefits (e.g. by a discount factor), and the allowance for uncertainties (e.g. by implementation of a sensitivity analysis). The decision analysis can be based on clinical trial data, on retrospective or administrative databases, or on modelling. The choice of outcome measures is the key issue in an economic evaluation. In cost-effectiveness analysis, benefits are usually measured in natural units. This is the form of economic evaluation most frequently used in nuclear medicine. Endpoints of effectiveness applied in studies in this field have been procedures avoided, procedures initiated, cardiac events, survival probability, morbidity, quality of life and protracted or failed surgical procedures. In other instances, surrogate endpoints have been used such as metastases detected, staging, viability or tumour response. This, however, limits comparability of cost-effectiveness considerably, as proof of a change in the health outcome cannot be obtained. Measures of utility such as QALYs (quality-adjusted life years) have so far only been applied for decision tree analysis. Useful examples of economic evaluation studies in nuclear medicine are presented here for fluorodeoxyglucose positron emission tomography (FDG-PET) in the preoperative staging of non-small cell lung cancer, for FDG-PET in differentiating indeterminate solitary pulmonary nodules, for somatostatin receptor scintigraphy in detecting metastases of carcinoid tumours, for routine preoperative scintigraphy with sestamibi in patients with parathyroid adenoma, for periodic measurement of thyroid-stimulating hormone in detecting mild thyroid failure, for diagnostic algorithms including a lung scan in patients with suspected pulmonary embolism, for myocardial perfusion imaging as an incremental prognostic factor in patients with coronary artery disease, and for the use of radioiodine as first-line therapy of Graves' hyperthyroidism and of toxic nodular goitres. Further evaluations of effectiveness or utility should be carried out within a multidisciplinary framework to ensure that nuclear medical procedures are included in the general management guidelines.

Additional or expensive diagnostic imaging had to prove prospectively their diagnostic efficacy, their therapeutic efficacy, or their patient-outcome efficacy. The adherence to methodologic standards in the cost-effectiveness literature is required. Based on the bone scintigraphy in oncologic patients with a low prevalence of bone metastases, the cost-effectiveness is questionable. The economic role of 99m-Tc MIBI mammoscintigraphy and of the imaging for carcinomas of unknown origin is discussed controversially. Based on the reimbursement of the positron emission tomography (PET) in the USA and in Switzerland, cost-effectiveness literature and decision trees for cost-utility analyses are reviewed. PET imaging was cost-effective in non-small-cell lung cancer, in solitary pulmonary nodules, in recurrent colorectal cancer, in metastatic melanoma and in recurrent head and neck cancer with reduced costs of management. The German health insurance calls for PET-data based on the national reimbursement.

Background: The aim of this study was to evaluate the use and reliability of the new positron emission tomography (PET)-based response criteria for interim positron emission tomography (iPET) in patients with paediatric Hodgkin’s lymphoma (pHL). Particular emphasis was put on interobserver variability and on identification of a visual cut-off defining patients with very low risk for relapse.Patients and methods: The iPET scans of 39 pHL patients were evaluated in two independent centres by two PET-experienced specialists in nuclear medicine (blinded read, centre consensus) each. The iPET scans were interpreted using a 5-point scale and were compared with the outcome. Cohen's kappa-test (κ) was used to analyse the interobserver agreement.Results: Concordant ratings were assessed in 19 patients with iPET-negative findings, in 11 patients with iPET-positive findings and in 2 patients with inconclusive ratings. A ‘substantial agreement’ between attended centres was achieved (κ = 0.748). All patients suffering relapse were concordantly identified, taking mediastinal blood pool structures (MBPS) as visual cut-off between PET-positive and PET-negative findings, respectively. All pHL patients with uptake lower than or equal to MBPS remained in complete remission.Conclusion(s): The iPET interpretation assured low interobserver variability. High sensitivity for identification of pHL patients suffering relapse is achieved if [18F]-fluorodeoxyglucose uptake above the MBPS value is rated as a PET-positive finding. [ABSTRACT FROM PUBLISHER]