What this study is
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.
What's being tested
- PET/CT Scan
Intervention · 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 · 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).
Study details
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Thyroid Carcinoma · Metastatic Thyroid Carcinoma
- Enrolling
- 75 people
- Starts
- 2018-08-21
- Est. completion
- 2027-08
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Age less than 18 years.
- Patients who are pregnant.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMemorial Sloan Kettering Cancer Center
New York, New York, United States
- Ravinder Grewal, MD · Contact212-639-2872
- Steven Larson, MD · Contact646-888-2212
- Ravinder Grewal, MD · Principal investigator
Recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 18-253
Principal investigator
Ravinder Grewal, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.