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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Maya Aslam
Maya.Aslam@ucsf.edu
(415) 514-8987
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 58
Treatments
Experimental: Intervention: I-124 PET/CT
All participants will be administered an oral dose of 60 to 85 megabecquerel (MBq) +/- 10% for I-124 (capsule) prior to the Positron Emission Tomography (PET) imaging. Scan coverage will extend from the vertex to the mid-thighs and in certain circumstances, coverage may be extended to the toes. Imaging will be acquired 20-28 hours after I-124 administered. Participants will be followed up for any adverse events for up to 5 days after the scan has been completed.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: Thomas Hope

This content was sourced from clinicaltrials.gov