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

NCT06961084 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 249212NCI-2025-03041
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Keywords

Imaging Studies

Outcome Measures

Primary Outcomes (2)

• Proportion of agreement between I-124 PET and I-123/I-131 SPECT (participant)

  Participant-level agreement between I-124 PET and the combination of I-123/I-131 SPECT will be measured. A participant will be classified as showing agreement only if all six regions demonstrate agreement; disagreement in one or more regions will result in a classification of disagreement. Positive percent agreement (PPA) and negative percent agreement (NPA) will be reported with corresponding 95% confidence intervals.

  1 day

• Number of agreement between 1-124 PET and 1-123/1-131 SPECT (region)

  Region-level agreement between 1-124 PET and the combination of 1-123/1-131 SPECT will be determined by Individual reader and through a consensus read. A region is in agreement if I-124 PET and I-123/I-131 SPECT results align, either as true positive (both positive) or true negative (both negative). Disagreement occurs when the results diverge, categorized as false positive (I-124 PET positive, but I-123/I-131 SPECT negative) or false negative (I-124 PET negative, but I-123/I-131 SPECT positive).

  1 day

Secondary Outcomes (14)

• Overall specificity of I-124 PET for detection of metastatic thyroid cancer (participant)

  1 day

• Overall specificity of I-124 PET for detection of metastatic thyroid cancer (region)

  1 day

• Overall sensitivity of I-124 PET for detection of metastatic thyroid cancer (participant)

  1 day

• Overall sensitivity of I-124 PET for detection of metastatic thyroid cancer (region)

  1 day

• Reclassification Rate

  1 day

Study Arms (1)

Intervention: I-124 PET/CT

EXPERIMENTAL

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.

Drug: Iodine-124; Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT)

Interventions

Iodine-124 DRUG

Given Orally

Also known as: I-124, I-124 Radioisotope

Intervention: I-124 PET/CT

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

Combination of PET and CT imaging

Also known as: PET/CT

Intervention: I-124 PET/CT

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 13 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.

You may not qualify if:

• Unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
• Known pregnancy.

Sponsors & Collaborators

• Thomas Hope: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94122, United States

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Iodine-124; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Thomas Hope, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Aslam

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)