NCT03647358 · Memorial Sloan Kettering Cancer Center
Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
What this study is about
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.
View original scientific description
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.
Interventions
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. (If a holiday is present in the work week, 124I can be administered orally on Day 2, if needed).
Primary outcome measures
number of individual lesions response
Time frame: 1 year
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations