Thyroid Cancer
Conditions
Brief summary
Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer.
Interventions
DIAGNOSTIC_TESTPET/CT scan F18-PSMA-11
PET/CT scan with F18-PSMA-11
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Belgium
Outcome results
None listed