Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Single-centre, Feasibility Study to Evaluate the Use of 18F-PSMA PET/CT in Patients With Biochemically Active Medullary Thyroid Cancer

Conditions
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Medullary Thyroid Cancer, Medullary Thyroid Carcinoma, Thyroid Carcinoma, Medullary, Thyroid Cancer, Medullary

Intervention / Treatment
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* Drug: 18F-PSMA-1007


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT<br>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<br>* As explained under 'Arms'.<br>* Other names: Fluorine-18 labeled prostate specific membrane antigen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer. | Patient- and lesion-based sensitivity. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSMA PET/CT, 18F-PSMA PET/CT, Fluorine-18 Labeled Prostate Specific Membrane Antigen, Prostate Specific Membrane Antigen, Thyroid Cancer, Medullary Thyroid Cancer, Medullary Thyroid Carcinoma