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

Phase 2

Completed

• Conditions: Thyroid Cancer

• Registration Number: NCT05175404
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-30
• Study First Posted: 2022-01-03
• Study Start: 2022-01-24
• Primary Completion: 2023-07-18
• Study Completion: 2023-07-18
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Demonstrate uptake of 18F-PSMA-11 in RAI-RTC	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.

Secondary Outcome Measures

Name	Time	Method
Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis.	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	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.	60 minutes +- 5 minutes after injection 18F-PSMA-11
Perform a semi-quantitative analysis of radiotracer uptake in lesions.	60 minutes +- 5 minutes after injection 18F-PSMA-11
Perform a lesion detection rate analysis on organ level.	60 minutes +- 5 minutes after injection 18F-PSMA-11
Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET	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.	Within 1 year

Trial Locations

Locations (1)

University hospital Ghent; 🇧🇪 Ghent, Belgium