Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

Thyroid Carcinoma Clinical Trial

Official title:

Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03647358
• Other study ID #: 18-253
• Status: Recruiting
• Phase: Phase 1
• Start date: August 21, 2018
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Ravinder Grewal, MD
• Phone: 212-639-2872
• Email: grewalr[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Thyroid Carcinoma
• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Device:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year

External Links

•   Memorial Sloan Kettering Cancer Center