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

Part of paid clinical trials in San Francisco, California.

Sponsor
Thomas Hope
Study ID
NCT06961084
Phase
PHASE2
Status
Recruiting
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Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iodine-124 — DRUG
    Given Orally
  • Positron Emission Tomography (PET)/Computerized tomography (CT) — PROCEDURE
    Combination of PET and CT imaging

Study Details

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.

Key Dates

Start date
Dec 4, 2025
Status verified
Apr 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
62 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94122
[email protected]
877-827-3222
Thomas Hope, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Francisco· San Francisco, CA

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