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

Sponsor

University Medical Center Groningen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05534594

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medullary Thyroid Cancer Medullary Thyroid Carcinoma Thyroid Carcinoma, Medullary Thyroid Cancer, Medullary	Drug: 18F-PSMA-1007	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT 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'. Other Names: Fluorine-18 labeled prostate specific membrane antigen

Arm

Intervention/Treatment

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

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'.

Other Names:

Fluorine-18 labeled prostate specific membrane antigen

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 calcitonin values. [Up to 2 years]
Assess the correlation between 18F-FDG uptake and serum calcitonin (ng/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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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