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

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

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

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Diagnostic Test: PET/CT scan F18-PSMA-11


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PET/CT scan F18-PSMA-11|PET/CT scan with F18-PSMA-11|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |