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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05175404
• Other study ID #: BC-09501
• Status: Completed
• Phase: Phase 2
• Start date: January 24, 2022
• Est. completion date: July 18, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Diagnostic Test:
• PET/CT scan F18-PSMA-11
PET/CT scan with F18-PSMA-11

Locations

Country	Name	City	State
Belgium	University hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate uptake of 18F-PSMA-11 in RAI-RTC	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	Perform a semi-quantitative analysis of radiotracer uptake in lesions.		60 minutes +- 5 minutes after injection 18F-PSMA-11
Secondary	Perform a lesion detection rate analysis on organ level.		60 minutes +- 5 minutes after injection 18F-PSMA-11
Secondary	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
Secondary	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
Secondary	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
Secondary	Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET		60 minutes +- 5 minutes after injection 18F-PSMA-11
Secondary	Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.		Within 1 year