Comparison of I-124 PET/CT to I-123 Whole Body Imaging for the Diagnosis of Thyroid
Thomas Hope
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 of metastatic thyroid cancer has been performed with whole body I-131 and Iodine 123 (I-123) imaging for many decades and use I-123 for staging studies. Iodine 124 (I-124) is a radioisotope of iodine which emits a positron and is imaged using PET (positron emission tomography). This is a single arm prospective trial that evaluates the ability of Iodine-124 (I-124) to detect metastatic thyroid cancer compared to non-interventional, usual care I-123 and I-131 images.
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 composite standard. 2. Reclassification rate of I-124 PET compared to I-123 SPECT. 3. Inter-reader variability for I-124 PET and I-123 SPECT. 4. Safety of I-124 PET. 5. Participant level detection rate for I-124 in the overall population. 6. Participant level detection rate for I-124 in participants who have negative I-123 SPECT. 7. Comparison of lesion detection between I-124 PET and 24 hour I-123 SPECT.…
Eligibility
- Age range
- 13+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age \>= 13 years. 2. Histopathologically confirmed differentiated thyroid cancer, with clinical concern for metastatic disease: 1. Metastatic disease seen on I-123 SPECT, Fluorodeoxyglucose (FDG) PET, CT scan or ultrasound. 2. Elevated thyroglobulin in participant after total thyroidectomy. i. Participants with an undetectable thyroglobulin will be allowed if thyroglobulin antibodies are present. 3. Meeting criteria for one of the following two populations: 1. American Thyroid Association (ATA) intermediate or high-risk thyroid cancer and planning on trea…
Interventions
- DrugIodine-124
Given Orally
- ProcedurePositron Emission Tomography (PET)/Computerized tomography (CT)
Combination of PET and CT imaging
Location
- University of California, San FranciscoSan Francisco, California