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

Not Applicable

Recruiting

• Conditions: Medullary Thyroid Cancer; Thyroid Cancer, Medullary; Thyroid Carcinoma, Medullary; Medullary Thyroid Carcinoma
• Interventions: Drug: 18F-PSMA-1007

• Registration Number: NCT05534594
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-19
• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-28
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT	18F-PSMA-1007	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.	Up to 2 years	Patient- and lesion-based sensitivity.

Secondary Outcome Measures

Name	Time	Method
Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT.	Up to 2 years	Comparison of patient- and lesion-based sensitivity. Comparison of Standardized Uptake Values (SUVs).
Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values.	Up to 2 years	Assess the correlation between 18F-PSMA uptake and serum calcitonin (ng/L) values.
Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.	Up to 2 years	Assess the correlation between 18F-PSMA uptake and serum CEA (ug/L) values.
Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.	Up to 2 years	Assess the correlation between 18F-FDG uptake and serum CEA (ug/L) values.
Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values.	Up to 2 years	Assess the correlation between 18F-FDG uptake and serum calcitonin (ng/L) values.

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands