Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03065218
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older;
* Diagnosed with differentiated thyroid carcinoma;
* At least one prior I-131 therapy, which may be remnant ablation, adjuvant treatment, and/or treatment of distant metastases,
* Elevated suppressed or stimulated thyroglobulin level (Tg) \> 10 ng/ml with or WITHOUT thyroglobulin antibodies ,
* All NEGATIVE standard diagnostic clinical imaging studies (SDCIS) = negative ultrasound (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or without contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography scan (18F-FDG PET) within the last 12 mos.
* If extensive diagnostic clinical imaging studies (EDCIS) of 18F-sodium fluoride positron emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate bone scan (99mTc MDP), AND brain CT or magnetic resonance (MR) are performed, these are also negative.
Exclusion Criteria:
* \< 18 years of age;
* Pregnant or breast feeding
* Any SDCIS or EDCIS that is positive and/or suggestive of recurrent and/or distant metastases secondary to DTC. If a study is indeterminate, this will be forwarded to a committee for review and resolution.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03065218
Study Brief:
Protocol Section:
NCT03065218