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

June 17, 2025 updated by: University Medical Center Groningen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Centre Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.
Time Frame: Up to 2 years
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.
Time Frame: Up to 2 years
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.
Time Frame: Up to 2 years
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.
Time Frame: Up to 2 years
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.
Time Frame: Up to 2 years
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.
Time Frame: Up to 2 years
Assess the correlation between 18F-FDG uptake and serum CEA (ug/L) values.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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