Recruiting
Phase 1

Iodine-124

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT03647358

Conditions

Thyroid Carcinoma

Metastatic Thyroid Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET/CT Scan

Iodine-124

Study Details

Brief summary:

The purpose of this study is to evaluate a new diagnostic imaging test, positron emission tomography (PET), with a different radioactive form of iodine called iodine-124. This form is able to accurately measure the amount of radioactive iodine uptake in the cancer. If the new test determines sufficient radioiodine uptake in the cancer, treatment will continue as usual. However, if the new test shows only low radioiodine uptake, a decision may be made that the benefit from radioiodine therapy is insufficient and that another form of therapy is preferred.

Conditions

Thyroid Carcinoma

Metastatic Thyroid Carcinoma

Study ID

NCT03647358

Start date

Aug 21, 2018

Status verified date

Apr, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults with thyroid carcinoma confirmed by pathology.
  • Adult thyroid carcinoma patients who have undergone total thyroidectomy
  • Adult thyroid carcinoma patients have metastatic disease or suspicion for metastatic disease, or are under a protocol intended to explore re-induction therapy for 131I uptake, and are about to undergo Thyrogen-assisted dosimetry, unless Thyrogen-assisted dosimetry is not required per standard of care.
  • The patient and physician are planning to administer 131I for therapy if persistent radioiodine-avid metastases are present.
  • All subjects must have measurable disease, documented within the previous six months by ultrasonography (US), MRI, FDG PET/CT, or CT scanning.

Exclusion Criteria:

  • Age less than 18 years.
  • Patients who are pregnant.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Lesion Dosimetry With Iodine-124

Patients will be administered 124I and undergo serial PET imaging consisting of up to 4 individual PET/CT scans. In order to perform a dual exponential fit, 4 scans are needed to obtain the necessary amount of data points required. Lesion dosimetry shall be performed based on the 124I PET scan data through tumor uptake and clearance pharmacokinetics. 10 patients, who sign consent for the sub-study, will be administered an additional tracer diagnostic activity of 124I (4 to 7 mCi). These patients will then undergo additional (up to a maximum of 4) PET scanning during radioiodine therapy at time points matched, if possible, to the days of the pre-therapy 124I dosimetry study.

Interventions

PET/CT Scan

Up to four whole-body PET scans (approximately 24, 48, and 120 hours post 124I oral dose) will be performed on one of the GE Discovery 710 or 690 PET scanners.

Iodine-124

Patients will receive 0.9 mg injections of rhTSH on two consecutive days. Twenty-four hours after the last injection of rhTSH each patient will receive approximately 5 mCi (range: 4-7 mCi) of 124I orally as a single dose. (If a holiday is present in the work week, 124I can be administered orally on Day 2, if needed).

Primary outcome measure

  • number of individual lesions response [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ravinder Grewal, MD

212-639-2872grewalr@mskcc.org

Steven Larson, MD

646-888-2212

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Ravinder Grewal, MD

212-639-2872

Steven Larson, MD

646-888-2212

Principal Investigator:

Ravinder Grewal, MD

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • Iodine-124
  • PET Scan
  • 18-253

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-14.