Brief Title
Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
Official Title
Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
number of individual lesions response
Condition
Thyroid Carcinoma
Intervention
PET/CT Scan
Study Arms / Comparison Groups
Lesion Dosimetry With Iodine-124
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
60
Start Date
August 21, 2018
Completion Date
August 2023
Primary Completion Date
August 2023
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ravinder Grewal, MD, 212-639-2872, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03647358
Organization ID
18-253
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
Ravinder Grewal, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
August 2022