An interventional study of 18F-PSMA-1007 in Medullary Thyroid Cancer, Medullary Thyroid Carcinoma and Thyroid Carcinoma, Medullary, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Diagnostic
Rationale: In patients with medullary thyroid cancer (MTC), molecular imaging is used to assess the extent of disease in the primary diagnostic process and follow-up period to determine possible therapeutic options. The currently most used tracer in clinical practice, F-18 labelled fluorodeoxyglucose (18F-FDG), does not accurately detect MTC tumors with an indolent growth rate. A new, complimentary tracer is warranted to detect different subtypes.
Objective: The primary objective is to assess the feasibility of using the F-18 labelled prostate specific membrane antigen (18F-PSMA) PET/CT for (re)staging patients with medullary thyroid cancer. The secondary objective is to compare the ability to detect MTC with the 18F-PSMA PET/CT to that of the 18F-FDG PET/CT.
Study design: Prospective, single-centre, feasibility study.
Study population: Patients (18 years of age or older) with biochemically and cytological/histological confirmed MTC, for whom the indication of an 18F-FDG PET/CT for tumor staging has already been determined on clinical grounds.
Main study parameters/endpoints: The primary outcome of this study is the performance (lesion-based//patient-based sensitivity) of the 18F-PSMA PET to detect MTC lesions in patients with cytologically/histologically confirmed disease. Secondarily, the performance of the 18F-PSMA PET will be compared to the 18F-FDG PET/CT.
65 studies on the registry are indexed under Carcinoma, Medullary; 17 are open to participants now.
This study's enrollment of 8 is below the median of 41 across 49 interventional studies indexed under Carcinoma, Medullary.
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Exclusion Criteria:
Only 1 arm exists in this study. Patients with Medullary Thyroid Cancer undergo a PET/CT after receiving the Fluorine-18 labeled prostate specific membrane antigen (18F-PSMA-1007) tracer intravenously. Each patient will undergo this process one time. Patients will receive 3 MBq/kg (+- 10%) in 8,3 ml (maximum 400 MBq). Waiting time after injection is 60 minutes. Scanning time is approximately 45 minutes.
Drug: 18F-PSMA-1007
As explained under 'Arms'.
Also known as: Fluorine-18 labeled prostate specific membrane antigen
Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.
Patient- and lesion-based sensitivity.
Time frame: Up to 2 years
Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT.
Comparison of patient- and lesion-based sensitivity. Comparison of Standardized Uptake Values (SUVs).
Time frame: Up to 2 years
Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values.
Assess the correlation between 18F-PSMA uptake and serum calcitonin (ng/L) values.
Time frame: Up to 2 years
Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.
Assess the correlation between 18F-PSMA uptake and serum CEA (ug/L) values.
Time frame: Up to 2 years
Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values.
Assess the correlation between 18F-FDG uptake and serum calcitonin (ng/L) values.
Time frame: Up to 2 years
Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.
Assess the correlation between 18F-FDG uptake and serum CEA (ug/L) values.
Time frame: Up to 2 years
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen