Back to resultsUse of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers
Primary Purpose
Thyroid Cancer
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
PET/CT scan F18-PSMA-11
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Cancer
Eligibility Criteria
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.
Sites / Locations
- University hospital Ghent
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Perform a semi-quantitative analysis of radiotracer uptake in lesions.
Perform a lesion detection rate analysis on organ level.
Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis.
Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients
Compare the histological expression of PSMA on already available tumor samples with the uptake of lesions on PSMA PET.
Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET
Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.
Full Information
NCT ID
NCT05175404
First Posted
December 14, 2021
Last Updated
August 23, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05175404
Brief Title
Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers
Official Title
Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
July 18, 2023 (Actual)
Study Completion Date
July 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT scan F18-PSMA-11
Intervention Description
PET/CT scan with F18-PSMA-11
Primary Outcome Measure Information:
Title
Demonstrate uptake of 18F-PSMA-11 in RAI-RTC
Description
Confirmation in PET-scan that lesions in RAI-RTC show uptake of 18F-PSMA-11, above background activity in the bloodpool.
Time Frame
60 minutes +- 5 minutes after injection 18F-PSMA-11
Secondary Outcome Measure Information:
Title
Perform a semi-quantitative analysis of radiotracer uptake in lesions.
Time Frame
60 minutes +- 5 minutes after injection 18F-PSMA-11
Title
Perform a lesion detection rate analysis on organ level.
Time Frame
60 minutes +- 5 minutes after injection 18F-PSMA-11
Title
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
Title
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
Title
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
Title
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
Title
Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.
Time Frame
Within 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University hospital Ghent
City
Ghent
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers
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