Status:
RECRUITING
Comparison of I-124 PET/CT for the Diagnosis of Thyroid Cancer
Lead Sponsor:
Thomas Hope
Collaborating Sponsors:
United States Department of Defense
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Persons diagnosed with thyroid cancer are often treated initially with a thyroidectomy, which is followed by ablation using Iodine-131, a therapy which has been shown to be effective and safe. Imaging...
Detailed Description
PRIMARY OBJECTIVES: 1\) Agreement between 1-124 PET and 1-123/1-131 SPECT. SECONDARY OBJECTIVES: 1. Sensitivity and specificity of I-124 PET to detect metastatic thyroid cancer compared to composit...
Eligibility Criteria
Inclusion
- Age \>= 18 years.
- Histopathologically confirmed differentiated thyroid cancer, with clinical concern for metastatic disease:
- Metastatic disease seen on I-123 SPECT, Fluorodeoxyglucose (FDG) PET, CT scan or ultrasound.
- Elevated thyroglobulin in participant after total thyroidectomy.
- i. Participants with an undetectable thyroglobulin will be allowed if thyroglobulin antibodies are present.
- Meeting criteria for one of the following two populations:
- American Thyroid Association (ATA) intermediate or high-risk thyroid cancer and planning on treatment using I-131.
- Metastatic disease on imaging (CT, MRI, ultrasound or FDG PET), and considering localized therapy such as surgery and radiation therapy.
- Undergone total thyroidectomy.
- Planned I-123 imaging within 45 days after enrollment.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion
- Unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Known pregnancy, per institutional policy.
Key Trial Info
Start Date :
July 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06961084
Start Date
July 14 2025
End Date
March 31 2026
Last Update
January 7 2026
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94122