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RecruitingNCT03647358Updated Sep 10, 2026

Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

A Phase 1 interventional study of PET/CT Scan and Iodine-124 in Thyroid Carcinoma and Metastatic Thyroid Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Thyroid Carcinoma
  • Metastatic Thyroid Carcinoma

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Keywords

  • Iodine-124
  • PET Scan
  • 18-253
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study 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.

    Device: PET/CT Scan · Drug: Iodine-124

Interventions

  • DevicePET/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.

  • DrugIodine-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).

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What researchers measure

Primary outcomes

  1. number of individual lesions response

    This will be accomplished using a logistic regression model using lesion as the unit of analysis and adjusting for possible correlation between lesions on the same patient using a random effect at the patient level. by RECIST 1.1

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    • Ravinder Grewal, MD · Contact · 212-639-2872
    • Steven Larson, MD · Contact · 646-888-2212
    • Ravinder Grewal, MD · Principal investigator
    Recruiting
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References and documents

Publications

  • Mauguen A, Grewal RK, Augensen F, Abusamra M, Mahajan S, Jayaprakasam VS, Osborne J, Haque S, Wong BZY, Ghossein RA, Fagin J, Schӧder H, Tuttle RM, Ho A, Humm JL, Larson SM. The use of single-timepoint images to link administered radioiodine activity (MBq) to a prescribed lesion radiation-absorbed dose (cGy): a regression-based prediction interval tool for the management of well-differentiated thyroid cancer patients. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):2971-2983. doi: 10.1007/s00259-023-06240-1. Epub 2023 May 12. PubMed 37171634 ↗
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Registry details

Key details

Study ID
NCT03647358
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Aug 27, 2018
Start date
Aug 21, 2018
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Ravinder Grewal, MD
Contact
grewalr@mskcc.org
212-639-2872
Steven Larson, MD
Contact
646-888-2212
Ravinder Grewal, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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