EUCTR2021-000456-19-BE
Active, not recruiting
Phase 1
se of 18F-PSMA-11 PET for detection of lesions in iodine refractory thyroid cancers
niversity Hospital Ghent0 sites20 target enrollmentSeptember 29, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospital Ghent
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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.
- •\-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 effective contraceptive methods (failure rate less than 1% per year when used consistently and correctly: combined hormonal contraception associated with inhibition of ovulation, progestogen\-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone\-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 10
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\-Patient has known other active malignancy.
- •\-Patient is potentially pregnant (urinary hCG test can be performed in case of doubt) or breastfeeding.
- •\-Patient is mentally or legally incapacitated.
Outcomes
Primary Outcomes
Not specified
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