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

NCT05534594 | Completed DMC

• 1 other identifier: 202200014
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Medullary Thyroid Cancer; Medullary Thyroid Carcinoma; Thyroid Carcinoma, Medullary; Thyroid Cancer, Medullary

Keywords

PSMA PET/CT; 18F-PSMA PET/CT; Fluorine-18 Labeled Prostate Specific Membrane Antigen; Prostate Specific Membrane Antigen; Thyroid Cancer; Medullary Thyroid Cancer; Medullary Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  Patient- and lesion-based sensitivity.

  Up to 2 years

Secondary Outcomes (5)

• Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT.

  Up to 2 years

• Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values.

  Up to 2 years

• Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.

  Up to 2 years

• Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values.

  Up to 2 years

• Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.

  Up to 2 years

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

18F-PSMA-1007 DRUG

As explained under 'Arms'.

Also known as: Fluorine-18 labeled prostate specific membrane antigen

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with prostate cancer or renal cell carcinoma
• Pregnant patients
• Recent neck surgery (\<3 months ago)

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Medullary; Thyroid cancer, medullary; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 9, 2022
• Study Start: August 19, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)