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

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Medullary Thyroid Carcinoma; Thyroid Cancer, Medullary; Thyroid Carcinoma, Medullary; Medullary Thyroid Cancer

Treatments: Drug: 18F-PSMA-1007

Study type: Interventional

Funder types: Other

Identifiers

NCT05534594

202200014

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT

Experimental group

Description:

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.

Treatment:

Drug: 18F-PSMA-1007