RECRUITINGPhase 2INTERVENTIONAL

Comparison of I-124 PET/CT for the Diagnosis of Thyroid Cancer

Comparison of I-124 PET/CT to I-123 Whole Body Imaging for the Diagnosis of Thyroid

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age \>= 18 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 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 willing to sign a consent form document, and the willingness to sign it. Who Should NOT Join This Trial: 1. Unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation. 2. Known pregnancy, per institutional policy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age \>= 18 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 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 consent document, and the willingness to sign it. Exclusion Criteria: 1. Unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation. 2. Known pregnancy, per institutional policy.

Treatments Being Tested

DRUG

Iodine-124

Given Orally

PROCEDURE

Positron Emission Tomography (PET)/Computerized tomography (CT)

Combination of PET and CT imaging

Locations (1)

University of California, San Francisco

San Francisco, California, United States