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 or poorly differentiated thyroid cancer. 3. Meeting criteria for one of the following two populations: 1. American Thyroid Association (ATA) intermediate or high-risk thyroid cancer and planning on treatment using I-131. 2. Metastatic disease on imaging (CT, MRI, ultrasound or FDG PET), and considering localized therapy such as surgery and radiation therapy. 4. Undergone total thyroidectomy. 5. Planned I-123 imaging within 45 days after enrollment. 6. Ability to understand a written informed consen…
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