Using I-124 PET/CT to find metastatic thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm prospective imaging study that gives participants an I-124 PET/CT and compares the findings to routine I-123 and post-treatment I-131 imaging obtained from the medical record. The primary aim is to measure agreement between I-124 PET and I-123/I-131 SPECT, with secondary aims including sensitivity, specificity, reclassification rate, inter-reader variability, and safety. A subset of participants will undergo additional imaging over five days for dosimetry and absorbed-dose prediction. Participants are followed by phone for up to 3–5 days to capture adverse events.

Why it matters

Who can join: the full rules

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 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.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Thomas Hope, MD — University of California, San Francisco
• Study coordinator: Maya Aslam
• Email: Maya.Aslam@ucsf.edu
• Phone: (415) 514-8987

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.