Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

NCT ID: NCT03647358

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-21
• Study Completion Date: 2026-08-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PET/CT Scan

Intervention Type: DEVICE

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

Intervention Type: DRUG

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).

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.

Intervention Type: DEVICE

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravinder Grewal, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ravinder Grewal, MD

Role: CONTACT

grewalr@mskcc.org

212-639-2872

Steven Larson, MD

Role: CONTACT

646-888-2212

Facility Contacts

Ravinder Grewal, MD

Role: primary

212-639-2872

Steven Larson, MD

Role: backup

646-888-2212

References

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.

Reference Type: DERIVED

PMID: 37171634 (View on PubMed)

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

18-253

Identifier Type: -

Identifier Source: org_study_id