Medullary Thyroid Cancer Clinical Trial
— MIMETICOfficial title:
Prospective, Single-centre, Feasibility Study to Evaluate the Use of 18F-PSMA PET/CT in Patients With Biochemically Active Medullary Thyroid Cancer
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older - Histological or cytological proven MTC - Biochemical evidence of disease activity (elevated/increasing calcitonin and/or CEA) - Clinical indication for an 18F-FDG PET/CT - Able to follow instructions to participate in the study - Able to give informed consent Exclusion Criteria: - Patients with prostate cancer or renal cell carcinoma - Pregnant patients - Recent neck surgery (<3 months ago) |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Centre Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer. | Patient- and lesion-based sensitivity. | Up to 2 years | |
Secondary | 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). | Up to 2 years | |
Secondary | 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. | Up to 2 years | |
Secondary | 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. | Up to 2 years | |
Secondary | 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. | Up to 2 years | |
Secondary | 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. | Up to 2 years |
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