Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers

February 27, 2025 updated by: University Hospital, Ghent
Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

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

  • Belgium
      • Ghent, Belgium
        • University Hospital Ghent

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:

  • Patient is 18 years or older.
  • Signed Informed Consent.
  • Subject is diagnosed with a histologically confirmed differentiated thyroid carcinoma, that is considered RAI refractory. There is evidence of persisting or recurrent disease, based on serum thyroglobulin levels and/or medical imaging.
  • Subject should have a routine clinical 18F-FDG PET/CT performed within two months prior to the study scan.
  • Female patients should be either post-menopausal, surgically sterile, or using highly effective contraceptives (methods that can achieve a failure rate of less than 1%: combined hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).

Exclusion Criteria:

  • Patient has a known other active malignancy.
  • Subject is potentially pregnant (urinary test can be performed in case of doubt) or breastfeeding.
  • Patient is mentally or legally incapacitated.

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
Other: Overal Trial
only one arm in this trial
Diagnostic test: PET/CT scan F18-PSMA-11
PET/CT scan with F18-PSMA-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate uptake of 18F-PSMA-11 in RAI-RTC
Time Frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Confirmation in PET-scan that lesions in RAI-RTC show uptake of 18F-PSMA-11, above background activity in the bloodpool.
60 minutes +- 5 minutes after injection 18F-PSMA-11

Secondary Outcome Measures

Outcome Measure
Time Frame
Perform a semi-quantitative analysis of radiotracer uptake in lesions.
Time Frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
60 minutes +- 5 minutes after injection 18F-PSMA-11
Perform a lesion detection rate analysis on organ level.
Time Frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
60 minutes +- 5 minutes after injection 18F-PSMA-11
Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis.
Time Frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
60 minutes +- 5 minutes after injection 18F-PSMA-11
Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients
Time Frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
60 minutes +- 5 minutes after injection 18F-PSMA-11
Compare the histological expression of PSMA on already available tumor samples with the uptake of lesions on PSMA PET.
Time Frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
60 minutes +- 5 minutes after injection 18F-PSMA-11
Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET
Time Frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
60 minutes +- 5 minutes after injection 18F-PSMA-11
Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.
Time Frame: Within 1 year
Within 1 year

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 24, 2022

Primary Completion (Actual)

July 18, 2023

Study Completion (Actual)

July 18, 2023

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-09501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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