[Guideline for Radioiodine Therapy for Benign Thyroid Diseases (6/2022 - AWMF No. 031-003)]. / DGN-Handlungsempfehlung (S1-Leitlinie): Radiojodtherapie bei benignen Schilddrüsenerkrankungen (Stand 6/2022 ­ AWMF-Registernummer: 031-003).

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.

Combined Early and Late [68Ga]PSMA-HBED-CC PET Scans Improve Lesion Detectability in Biochemical Recurrence of Prostate Cancer with Low PSA Levels.

PURPOSE: Our aim was to evaluate the benefit of early (1 h post-injection (p.i.)) and late (3 h p.i.) [68Ga]PSMA-HBED-CC positron emission tomography (PET)/x-ray computed tomography (CT) imaging for detection of biochemical recurrence (BCR) of prostate cancer (PCa). PROCEDURES: Seventy patients with BCR of the PCa and prostate-specific antigen (PSA) levels of less than 2.0 µg/l were subjected to [68Ga]PSMA-HBED-CC PET (mean injected activity 180 MBq). While early imaging contained whole body scans, late imaging was confined to the pelvis and the lower abdomen. Uptake in suspicious lesions was analyzed by peak and maximum standardized uptake values (SUVpeak/max). Tumor-to-background ratios were calculated for all lesions in which the liver served as reference organ. The Wilcoxon matched-pair signed-rank test was used to compare the uptake in suspicious lesions between early and late imaging. Follow-up data were used to validate the existence of the additionally detected lesions. RESULTS: Forty-four of the 70 patients thus examined were interpreted as PSMA-positive in early and/or late scans while 26 remained without suspicion of PSMA tracer uptake. A total of 70 suspicious lesions were analyzed. Ten tumor-suspicious lesions from seven different patients were better or exclusively visible in the late measurements while three tumor-suspicious lesions from three different patients were better or exclusively visible in the early images. A validation by follow-up data was possible for 11 of these 13 additionally detected lesions. In direct comparison between early and late imaging, the mean SUVmax in PSMA-positive lesions was 74 % higher (p < 0.001) and the mean SUVpeak was 36 % higher (p = 0.001) in the late scans. The SUVmean in the reference regions was decreasing in the late measurements, whereas the mean TBR increased by a factor of 3 (p < 0.001). Taking confirmed lesions only into account, we estimated a 10 % gain in additionally detected PSMA-positive lesions (7/70) within the patient cohort. CONCLUSIONS: The time period between injection and data acquisition influences the detection rate of [68Ga]PSMA-HBED-CC PET/CT. In biochemical recurrence with low PSA levels, late [68Ga]PSMA-HBED-CC PET/CT imaging offers frequent advantages with regard to lesion contrast.

Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18.

Background: Bone marrow (BM) involvement defines advanced-stage Hodgkin lymphoma and thus has impact on the assignment to treatment. Our aim was to evaluate whether the established BM biopsy may be omitted in patients if 18F-fluorodeoxyglucose positron emission tomography (PET) scanning is carried out during staging. Patients and methods: Our analysis set consisted of 832 Hodgkin lymphoma patients from the German Hodgkin Study Group trials HD16, HD17, and HD18 who underwent both PET scanning and BM biopsy before treatment. All PET studies were centrally reviewed and BM was categorized as showing focal involvement or not. Results: Taking BM biopsy as reference standard, baseline PET showed a negative predictive value of 99.9% [95% confidence interval (CI) 99.2% to 100%] with true-negative results in 702 of 703 cases. The sensitivity of PET for detecting BM involvement was 95.0% (95% CI 75.1% to 99.9%) as it could identify 19 out of 20 patients with positive BM biopsy. Moreover, PET found 110 additional subjects with focal BM lesions who would have been considered negative by biopsy. Conclusions: When compared with BM biopsy, PET was able to detect focal BM lesions in a large number of additional patients. This indicates that conventional BM biopsy may substantially underestimate the actual incidence of BM involvement. Given the high negative predictive value, baseline PET scanning can safely be used to exclude BM involvement in Hodgkin lymphoma. BM biopsy should be considered only in such patients in whom PET-detected lesions lead to a change of treatment protocol. Registered trials: The trials included in this analysis were registered at ClinicalTrials.gov: HD16-NCT00736320, HD17-NCT01356680, and HD18-NCT00515554.

[Lutetium-177-PSMA radioligand therapy : Consensus within the framework of GKV-funded care between the university hospitals in Aachen, Bonn, Düsseldorf, Essen, and Cologne and the MDK Nordrhein]. / Lutetium-177-PSMA-Radioligandentherapie : Konsensus im Rahmen der GKV-finanzierten Versorgung zwischen den Hochschulkliniken in Aachen, Bonn, Düsseldorf, Essen und Köln und dem MDK Nordrhein.

In the last 3 years, Lutetium-177 prostate-specific membrane antigen radioligand therapy (Lu-177-PSMA-RLT) has received increasing attention in nuclear medicine as a new form of treatment for castration-resistant metastatic prostate cancer. This therapy combines the radionuclide Lutetium-177, which has been therapeutically used in nuclear medicine for many years, with a molecular target of the transmembrane prostate-specific membrane antigen expressed by prostate cancer cells. Since there are no prospective randomized studies on Lu-177-PSMA-RLT and the question of reimbursement has repeatedly been the subject of review by the MDK Nordrhein (Medischenische Dienst der Krankenversicherung), there was a desire because of the increasing number of patients being treated to clarify under which circumstances Lu-177-PSMA-RLT can be reimbursed by German statutory health insurance. The goals of this article are to help treating physicians understand how this new therapy option works, to integrate it in the overall therapy concept for castration-resistant metastatic prostate cancer, and, above all, to use Lu-177-PSMA-RLT-based on the current data-at the right place in the therapy sequence of castration-resistant metastatic prostate cancer.

Concordance in the interpretation of PET after chemotherapy in advanced stage Hodgkin lymphoma.

UNLABELLED: The aim was to analyze the degree of agreement between the central review panel and the local PET interpretation within the HD15 trial and its impact on subsequent treatment and progression free survival. PATIENTS, METHODS: The analysis set consisted of 739 patients with residues ≥ 2.5 cm after 6 or 8 cycles of BEACOPPesc from the HD15 trial performed by the German Hodgkin Study Group. The recommendation for or against further radiotherapy was based on the central [(18)F]FDG-PET interpretation. Central PET interpretation was compared to the local PET interpretation and concordance was measured using Cohen's Kappa coefficient. Prognostic impact of the analysis of concordance between local and central PET interpretations was evaluated using progression free survival (PFS); groups were compared with the log rank test. RESULTS: The central panel rated 548 of 739 patients (74%) as PET negative. Of these, 513 were also rated as PET negative in the local PET interpretation. PET positivity was seen by central reviewers in the remaining 191 patients (26%), in concordance with local reviewers in 155 cases. Even though substantial agreement was found (Cohen's Kappa 0.81), the interpretation of the central PET review panel led to a different therapeutic recommendation in 71/739 (10%) patients. PFS was equally high in groups in which the therapeutic regime had been changed on the basis of the central panel decision. CONCLUSION: High concordance is found between local and central reviewers with regard to PET interpretation in residual tissue after intense chemotherapy. The existence of the central PET review panel allows the identification of additional patients as PET negative so that radiotherapy can be safely omitted (35 of 548 patients = 4.7%).

Complete metabolic response in a patient with repeatedly relapsed non-small cell lung cancer harboring ROS1 gene rearrangement after treatment with crizotinib.

A 55-year-old Caucasian woman with lung adenocarcinoma stage IV presented with repeated relapse after treatment with cytotoxic chemotherapy (carboplatin, gemcitabine, docetaxel, pemetrexed) and targeted agents (erlotinib, cetuximab, sunitinib). Comprehensive molecular diagnostics (EGFR-, ALK-, RAS-, BRAF-, PIK3CA-, HER2- and DDR2-aberrations) were performed and failed initially to detect any driver mutation. While the patient suffered from rapid deterioration of her general condition, in particular from progressive dyspnea due to lung metastases, we implemented screening for RET- and ROS1 translocations into our molecular diagnostic program based on recent reports of these new molecular subgroups in lung adenocarcinoma. On retesting the patient's tumor sample was found to harbor a ROS1-translocation. The patient was subsequently treated with crizotinib and experienced a pronounced clinical improvement corresponding to a complete metabolic response in (18)F-FDG-PET and a good and confirmed partial response in CT (RECIST 1.1). Our case exemplifies the need for rapid implementation of newly discovered rare genetic lung cancer subtypes in routine molecular diagnostics.

Disease-free survival in papillary and follicular thyroid carcinoma. Comparison between UICC 5th and 7th classifications of T stage, and the prognostic value of primary tumour size.

UNLABELLED: T stage was redefined for patients with differentiated thyroid carcinoma (DTC) between the 5th and 7th versions of the UICC tumour classification system. PATIENTS, METHODS: 636 patients (486 women, 150 men; mean age 49.1 ± 15.6 years, mean follow-up 4.6 years) who had been treated with ablative radioiodine therapy after thyroidectomy for papillary (PTC) or follicular thyroid carcinomas (FTC) were retrospectively assessed on occurrence of locoregional recurrent disease, or cervical lymph node or distant metastases. Disease-free survival was calculated from initial T stage, classified according to both versions of the UICC staging system and compared with the prognostic value of primary tumour size. Kaplan-Meier method and two measures of explained variation, (1) R2 based on the (partial) likelihood ratio statistic of the Cox proportional hazards model and (2) a model-free variant of a distance measure proposed by Schemper had the aim to detect the most advantageous classification. RESULTS: Of the 508 patients with PTC, 11 (2.2%) developed a local recurrence, 37 (7.3%) cervical lymph node and 23 (4.5%) distant metastases, 3 (2.3%), 8 (6.3%), and 18 (14.1%) were the numbers for the 128 FTC patients respectively. The two classification systems yielded an equal count of statistically significant differences regarding disease-free survival in patients with PTC while UICC 7th classification appeared slightly advantageous in patients with FTC. Regarding explained variation the UICC 7th classification tended to be superior to the UICC 5th classification, both in PTC and FTC, however statistical significance was not reached. CONCLUSION: The primary tumour size significantly added to the prognosis regarding local cervical and distant metastases.

Diagnostic value and therapeutic impact of (18)F-FDG-PET/CT in differentiated thyroid cancer. Results of a German multicentre study.

UNLABELLED: The clinical significance of (18)F-FDG-PET/CT in the follow-up of patients with differentiated thyroid carcinoma was evaluated and the results were compared with those of (18)F-FDG-PET, (131)I-whole-body scintigraphy including SPECT/CT (WBS) and ultrasound. In addition, it was the aim to investigate the impact of (18)F-FDG-PET/CT on the therapeutic management. PATIENTS, METHODS: 327 patients (209 women, 118 men; mean age 53 ± 18 years) with differentiated thyroid cancer (242 papillary, 75 follicular, 6 mixed, 1 Hürthle cell and 3 poorly differentiated tumours) were analyzed retrospectively at four tertiary referral centres. 289 (18)F-FDG-PET/CT and 118 (18)F-FDG-PET studies were performed in these patients between 2007 and 2010. In addition, an overall clinical evaluation was performed, including cytology, histology, thyroglobulin level, ultrasound, WBS, and subsequent clinical course in order to compare the molecular imaging results. Finally, the change in therapeutic management due to findings of (18)F-FDG-PET/CT was investigated. RESULTS: The sensitivity of (18)F-FDG-PET/CT was 92%, the specificity was 95%. Sensitivity and specificity of (18)F-FDG-PET alone were 67% and 93%, respectively. WBS showed a sensitivity of 65% and a specificity of 94%. The corresponding values of ultrasound were 37% and 94%, respectively. The sensitivity of (18)F-FDG-PET/CT in the group of patients with a negative WBS (n=194) amounted to 96%. When (18)F-FDG-PET/CT and WBS were considered in combination, tumour tissue was missed in only 2 out of 133 patients; when (18)F-FDG-PET and WBS were combined, tumour tissue was missed in 1 out of 24 patients. (18)F-FDG-PET/CT resulted in management change in 43% (n=57/133) with a decision on surgical approach in 20% (n=27/133). CONCLUSIONS: (18)F-FDG-PET/CT is superior to (18)F-FDG-PET alone in patients with differentiated thyroid cancer and has a direct impact on the therapeutic management of patients with suspected local recurrence or metastases, particularly in those with negative WBS.

Calcitonin screening in patients with thyroid nodules. Diagnostic value.

AIM: The positive predictive value (PPV) of a slightly elevated basal calcitonin (CT) for the diagnosis of medullary thyroid cancer (MTC) is still under debate. PATIENTS, METHODS: A total of 11270 patients with thyroid nodules underwent calcitonin screening. Patients with known elevation of CT, renal insufficiency, bacterial infection, alcohol abuse, proton-pump inhibitor therapy or autoimmune thyroid disease were excluded from further analysis. Serum CT was determined by the solid-phase, enzyme-labeled, two-site chemiluminescent immunoassay Immulite 2000. If possible, a pentagastrin test was done to differentiate cases of hypercalcitoninaemia. RESULTS: Hypercalcitoninsemia was found in 32 patients. 20 patients underwent surgery. In 10 patients a MTC was found. The PPV of hypercalcitoninaemia for MTC was 31%. The PPV increased to 50% for those patients who underwent surgery (10/20). A subgroup of 26 patients presented with basal CT between 13 and 50 pg/ml, 14 of them underwent surgery, in 4 cases evidence of MTC was revealed. This resulted in a PPV of 15% (4/26), although the value increased to 28% when only surgically treated patients were considered (4/14). CONCLUSION: Taking all clinical data into account, calcitonin screening has an acceptable PPV for medullary thyroid cancer in patients with thyroid nodules. Therefore, we recommend calcitonin screening in centers for thyroid disorders.

123I-FP-CIT SPECT imaging of the dopaminergic state. Visual assessment of dopaminergic degeneration patterns reflects quantitative 2D operator-dependent and 3D operator-independent techniques.

UNLABELLED: 123I-N-ω-fluoropropyl-2ß-carbomethoxy-3ß-(4-iodophenyl)nortropan (123I-FP-CIT) single photon emission computed tomography (SPECT) can be evaluated by both visual assessment and quantitative analysis to assess the striatal dopamine state in vivo. The aim of our study was to investigate if visual assessment according to a predefined image grading scale reflects the results of quantitative assessment techniques. PATIENTS, METHODS: 195 patients with a clinical diagnosis of idiopathic Parkinson's disease (n = 134), atypical parkinsonian syndrome (n = 47) or essential tremor (n = 14) were examined with 123I-FP-CIT SPECT and included in this retrospective study. Results were analysed according to predefined visual patterns of dopaminergic degeneration and graded as normal (grade 5) or abnormal (grade 1-4) independently by three raters. Quantitative two-dimensional (2D) operator-dependent, manual and three-dimensional (3D) operator-independent, automated approaches were used for quantitative analysis of the specific 123I-FP-CIT tracer binding ratio (SBR) for caudate and putamen. RESULTS: Sensitivity, specificity, PPV, NPV and diagnostic accuracy of visual assessment of 123I-FP-CIT SPECT for the diagnosis of a neurodegenerative Parkinson's syndrome were 99%, 86%, 99%, 86% and 98%, respectively. Visual assessment and quantitative analysis agreed well in evaluating the degree of dopaminergic degeneration. Significant differences (p<0.001) were found between degeneration patterns. Only between the so-called eagle wing degeneration and the normal pattern no significant differences in SBR caudate and putamen were found, neither by the quantitative manual (p = 1.00; p = 0.196) nor by the quantitative automated method (p=1.0; p = 0.785). Inter-rater agreement for visual assessment was substantial for all possible pairs of the three raters (κ = 0.70 to 0.74). Strong correlations were observed between the quantitative manual and quantitative automated methods for quantification of SBR caudatum (r = 0.920, r² = 0.846, p<0.001) and SBR putamen (r = 0.908, r²=0.824, p < 0.001). CONCLUSION: Visual assessment was highly consistent with the results obtained by quantitative analysis and showed a substantial inter-rater agreement between experienced and inexperienced raters. Our findings indicate that visual assessment might be a reliable analysis approach for clinical routine.

Recombinant human TSH increases uptake and effective half-life of radioiodine in thyroid hormone secreting metastases of follicular thyroid cancer.

Follicular thyroid cancer with thyroid hormone secreting metastases is an extremely rare condition, with only a few cases reported world-wide. We here present the case of a 64-year-old female patient affected by follicular thyroid cancer with extensive thyroid hormone secreting metastases leading to TSH-suppression. We have also summarized the relevant diagnostic and therapeutic approaches and describe, for the first time, the effects of rhTSH-application in this rare tumor entity. In this patient, we found that rhTSH increased ¹³¹I-uptake into the thyroid hormone secreting metastases and prolonged the effective half-life of ¹³¹I. These effects of rhTSH should be considered when fixed activities of ¹³¹I are prescribed.

Evaluation of interim PET response criteria in paediatric Hodgkin's lymphoma--results for dedicated assessment criteria in a blinded dual-centre read.

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.

Recombinant human TSH versus hypothyroidism. Cost-minimization-analysis in the follow-up care of differentiated thyroid carcinoma.

UNLABELLED: The primary aim of this study was to compare pharmacoeconomic effects of hypothyroidism secondary to hormone withdrawal (THW) and recombinant human TSH (rhTSH) for follow-up WBS in patients with differentiated thyroid cancer (DTC). The second aim was to determine patients' preference for one procedure or the other. PATIENTS, METHODS: This retrospective survey included 327 patients with DTC who underwent at least one in-hospital WBS with rhTSH between 1999 and 2006. They had also undergone THW for WBS. Patients received a two-page questionnaire via mail addressing five symptoms and ten items regarding managing their daily life which was answered by 61.6%. The responder group did not differ from the entire group. The medical and societal cost of both procedures for diagnostic WBS was calculated including direct and all ascertainable indirect cost for the reference year 2005. A sensitivity analysis included the German DRG system of 2007 and 2010. RESULTS: After THW, 94% of patients reported hypothyroid symptoms. Using rhTSH, symptoms occurred significantly less. As a result, 97% of patients favored rhTSH over THW. Mean absence from salaried work was 12.3 days after THW compared to 4 days with rhTSH. Family members of salaried employees missed 3 and 0.7 workdays after THW and rhTSH, respectively. Almost twice as often, medical attention was sought after THW (36%) compared to rhTSH (19 %). Undergoing THW, 48% of patients still used their car while hypothyroid. Our cost calculation revealed a slight benefit of about 89.00 Euro in favour of rhTSH stimulation. CONCLUSION: Hypothyroidism after THW causes significant morbidity and safety risks. The clinical and societal benefits associated with rhTSH are roughly gained at equivalent overall cost to that of THW.

[18F]-fluorodeoxyglucose-positron emission tomography for the assessment of histopathologic response and prognosis after completion of neoadjuvant chemotherapy in gastric cancer.

BACKGROUND AND OBJECTIVES: Neoadjuvant chemotherapy is applied to improve the prognosis of patients with advanced gastric cancer. However, only a major histopathological response will provide a benefit. Recent studies suggest that [(18)F]-fluorodeoxyglucose-positron-emission-tomography (FDG-PET) correlates with response and survival in patients with gastroesophageal adenocarcinomas undergoing neoadjuvant chemotherapy. We evaluated the potential of FDG-PET for the assessment of response and prognosis in the multimodality treatment of gastric cancer. METHODS: Study patients were recruited from a prospective observation trial. Forty two patients with advanced gastric cancer received neoadjuvant chemotherapy and subsequently 40 patients underwent standardized gastrectomy (2 patients with tumor progression had therapy limited to palliative chemotherapy without surgery). Histomorphologic regression was defined as major response when resected specimens contained <10% vital tumor cells. FDG-PET was performed before and 2 weeks after the end of neoadjuvant chemotherapy with assessment of the intratumoral FDG-uptake [pre-treatment standardized uptake value (SUV1); post-treatment SUV (SUV2); percentage change (SUVDelta%)]. RESULTS: Histomorphological tumor regression was confirmed as a prognostic factor (P = 0.039). No significant correlations between SUV1, SUV2, or SUVDelta% and response or prognosis were found. CONCLUSION: FDG-PET seems not to be an imaging system that effectively characterizes major/minor response and survival in patients with gastric cancer following multimodality treatment.

Risk stratification of patients with locally aggressive differentiated thyroid cancer. Results of the MSDS trial.

UNLABELLED: The Multicentre Study Differentiated Thyroid Cancer (MSDS) collective represents a well defined group of patients with locally aggressive thyroid carcinomas (pT4; AJCC/UICC 1997). The aim of the present study was to compare the survival of patients with minimum and extensive extrathyroidal growth according to the new AJCC/UICC TNM staging system 2009. PATIENTS, METHODS: The follow-up data of 347 patients were analysed. Patients were reclassified according to the current AJCC/UICC 2009 classification. The event-free and overall survival was evaluated using Kaplan-Meier analysis. In addition, postoperative complications and status of disease were documented. RESULTS: 327 patients were assigned to stage pT3 and 20 patients to stage pT4a, respectively. Median follow-up was 6.1 years (range 0.04-9.8 years). 92.5% of patients reached complete remission. There were 7.8 % recurrences in the thyroid bed, in locoregional lymph nodes and/or in distant sites. The overall survival was >98% both in pT3 and pT4a patients (p = n. s.). In contrast, the event-free survival was significantly less favourable in pT4a patients (p < 0.001). Using multivariate analysis the following parameters were significant predictors of event-free survival: histological tumour type, degree of extrathyroidal extension and nodal metastasis (p < 0.05). CONCLUSIONS: The MSDS patients with locally aggressive differentiated thyroid cancer showed an excellent overall survival during a median follow-up of 6.1 years. According to the current AJCC/UICC 2009 classification, pT3 patients with minimal extrathyroidal extension revealed a significantly better event-free survival than pT4a patients with extensive extrathyroidal growth.

[Amiodarone-induced thyroid gland dysfunctions]. / Amiodaron-induzierte Schilddrüsenfunktionsstörungen.

Amiodarone treatment affects thyroid status in about the half of patients. Amiodarone causes a wide spectrum of effects on the thyroid function including hypothyroidism and thyreotoxicosis. Amiodaron-induced thyroid dysfunction is the most reason for discontinuation of amiodaron therapy. In this report we describe amiodaron-induced thyroid dysfunction and the diagnostic and therapeutic challenges in such patients.

[Nuclear medical inpatient treatment in Germany - analysis of structured quality reports 2004-2008]. / Stationäre nuklearmedizinische Therapie in Deutschland - Analyse der strukturierten Qualitätsberichte 2004 bis 2008.

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.

[PET and diagnostic technology evaluation in a global clinical process. DGN's point of view]. / Vorbehalte der DGN zur Nutzenbewertung der PET durch das IQWiG.

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.

The use of thyrogen in the treatment of differentiated thyroid carcinoma: an intraindividual comparison of clinical effects and implications of daily life.

AIM: Withdrawal of levothyroxine with resultant hypothyroidism is still used in preparation for I-131 diagnostic whole-body scan (DWBS) and thyroglobulin (TG)-measurement in patients afflicted with differentiated thyroid cancer (DTC). Recombinant human thyroid-stimulating hormone (rhTSH) enhances TSH stimulation obviating the clinical and economical consequences of hypothyroidism. Primary aim of this study was an intraindividual comparison of diagnostic follow-up measurements under these two sets of conditions by taking clinical and socio-economic parameters into account. Second aim was to determine a clear patient preference for the one method or the other. METHODS: This non-interventional observational study included patients (n=192 signed informed consent, n=128 protocol compliant patients without need for therapeutic intervention) with DTC first treated by thyroidectomy and radioiodine ablation. Control visits including I-131 DWBS were planned at 3-6 months post-thyroidectomy after a phase (KU 1) of thyroid hormone withdrawal (THW) and again after 6-12 months later in a euthyroid state under exogenous stimulation with rhTSH (KU 2). Study design was open, prospective and multicentric. Data collected consisted of patient information (SF-12 (®) Health Survey), thyroid-specific results of clinical examinations and several aspects of daily life, e. g., employment, days of absence from work and other economic aspects. RESULTS: In contrast to KU 1, in KU 2 there is a highly significant improvement (p<0.0001) in all studied clinical symptoms and aspects of managing daily life. A significant increase of the SF-12 (®) health survey score could also be identified. Mental score showed a higher increase than physical score. Included patients were less absent from work before KU 2, (absent 4.5%, median 4 days in euthyroid state [range 2-5 d]), vs. before KU 1 (absent 47.8%, median 10 days in hypothyroid state [range 1-30 d]). After KU 2 7.7% of the euthyroid patients was absent from work (median 5 days) while 37.5% was after KU 1 (median 6 days). CONCLUSION: Included patients benefited subjectively and objectively from the use of rhTSH for diagnostic procedures in the treatment of DTC. A clear preference (127 of 128) of analyzed patients could be identified for exogenous stimulation with rhTSH.