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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

From the registry’s dates

  • Started Aug 2018; still recruiting 8 years 2 months later.
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.

02

Conditions studied

  • Thyroid Carcinoma
  • Metastatic Thyroid Carcinoma

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Keywords

  • Iodine-124
  • PET Scan
  • 18-253
03

In context

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

This study's planned enrollment of 75 is above the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults with thyroid carcinoma confirmed by pathology.
  • Adult thyroid carcinoma patients who have undergone total thyroidectomy
  • Adult thyroid carcinoma patients have 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 , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

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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.

  • 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).

06

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

07

Study locations

1 of 1 sites recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
    • Ravinder Grewal, MD · Contact212-639-2872
    • Steven Larson, MD · Contact646-888-2212
    • Ravinder Grewal, MD · Principal investigator
08

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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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2018 (actual). Primary completion is estimated for Aug 2027, 108 months after the start.

Of 38 phase 1 interventional studies under Thyroid Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 81. This study's planned 108 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2018
First posted
Aug 27, 2018
StartActual
Aug 21, 2018
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03647358
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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Studies of the drug tested here: Iodine-124

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