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NCT Number: NCT05534594

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

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Key information

Conditions

Medullary Thyroid Cancer Adenocarcinoma Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Medullary Thyroid Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Thyroid Cancer, Medullary Thyroid Carcinoma, Medullary Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

18F-PSMA-1007

Drug

As explained under 'Arms'.

Other names: Fluorine-18 labeled prostate specific membrane antigen

Primary outcomes

  1. Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.

    Time frame: Up to 2 years

    Patient- and lesion-based sensitivity.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: MIMETIC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 9, 2022
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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