Clinical trial NCT05175404: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory 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.

Primary outcomes:
measure: Demonstrate uptake of 18F-PSMA-11 in RAI-RTC
timeFrame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Secondary outcomes:
measure: Perform a semi-quantitative analysis of radiotracer uptake in lesions.
timeFrame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
measure: Perform a lesion detection rate analysis on organ level.
timeFrame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
measure: Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis.
timeFrame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
measure: Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients
timeFrame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
measure: Compare the histological expression of PSMA on already available tumor samples with the uptake of lesions on PSMA PET.
timeFrame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
measure: Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET
timeFrame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
measure: Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.
timeFrame: Within 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University hospital Ghent
Study officials:
References:
citation: Van den Broeck B, Debacker JM, Bauters W, Creytens D, Ferdinande L, Huvenne W, Lapauw B, Schelfhout V, Van Laeken N, Verroken C. Potential application of [18F]AlF-PSMA-11 PET/CT in radioiodine refractory thyroid carcinoma. EJNMMI Res. 2024 Sep 12;14(1):82. doi: 10.1186/s13550-024-01148-9.