NCT06961084 Comparison of I-124 PET/CT for the Diagnosis of Thyroid Cancer
| NCT ID | NCT06961084 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Thomas Hope |
| Condition | Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 62 participants in total. It began in 2025-12-04 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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.
Contact & Investigator
Thomas Hope, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06961084 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06961084 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06961084 currently recruiting?
Yes, NCT06961084 is actively recruiting participants. Contact the research team at Maya.Aslam@ucsf.edu for enrollment information.
Where is the NCT06961084 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06961084 clinical trial?
NCT06961084 is sponsored by Thomas Hope. The principal investigator is Thomas Hope, MD at University of California, San Francisco. The trial plans to enroll 62 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.