Recruiting
Phase 2

I-124

Sponsor:

Thomas Hope

Code:

NCT06961084

Conditions

Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

Iodine-124

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

Study Details

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.

Conditions

Thyroid Cancer

Study ID

NCT06961084

Start date

Dec 4, 2025

Status verified date

Jun, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

62 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Iodine-124

Given Orally

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

Combination of PET and CT imaging

Primary outcome measure

  • Proportion of agreement between I-124 PET and I-123/I-131 SPECT (participant) [ Time Frame: 1 day ]
  • Number of agreement between 1-124 PET and 1-123/1-131 SPECT (region) [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Maya Aslam

(415) 514-8987Maya.Aslam@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94122

Contacts

Maya Aslam

Maya.Aslam@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Thomas Hope, MD

More Information

Sponsor

Thomas Hope

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Imaging Studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thomas Hope on 2026-06-18.