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: Pts will be administered 124I & undergo serial PET imaging consisting of up to 4 individual PET/CT scans. In a set of 10 pts, consent will be sought to obtain additional PET/CT scans during the week of 131I therapy. In this study group, patients will receive an additional 4 to 7 mCi 124I tracer dose, alongside the 131I radioiodine therapy dose, for the purpose of imaging radioiodine lesional uptake during therapy. This will be the first study to compare the predicted lesion radiation absorbed doses in Gray derived from a pre-therapy test imaging dose to an imaging dose administered concomitant with 131I radioiodine therapy. Pts will be taken off-treatment on day 8, as days 9 & 10 are standard of care intervention. Subjects receiving RAI therapy may remain on-study & be followed for up to 1.5 years with standard of care anatomical imaging, or until they receive their next standard of care anatomical imaging (PET, CT, MRI, ultrasound) or are deemed lost to follow up by the study doctor.
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
100
Start Date
August 21, 2018
Completion Date
August 2022
Primary Completion Date
August 2022
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
December 2020