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Iodine-124 · 1 trial · 1 indication
Participant-level agreement between I-124 PET and the combination of I-123/I-131 SPECT will be measured. A participant will be classified as showing agreement only if all six regions demonstrate agreement; disagreement in one or more regions will result in a classification of disagreement. Positive percent agreement (PPA) and negative percent agreement (NPA) will be reported with corresponding 95% confidence intervals.
Region-level agreement between 1-124 PET and the combination of 1-123/1-131 SPECT will be determined by Individual reader and through a consensus read. A region is in agreement if I-124 PET and I-123/I-131 SPECT results align, either as true positive (both positive) or true negative (both negative). Disagreement occurs when the results diverge, categorized as false positive (I-124 PET positive, but I-123/I-131 SPECT negative) or false negative (I-124 PET negative, but I-123/I-131 SPECT positive).
| Arm | Type | Description |
|---|---|---|
| Intervention: I-124 PET/CT | EXPERIMENTAL | All participants will be administered an oral dose of 60 to 85 megabecquerel (MBq) +/- 10% for I-124 (capsule) prior to the Positron Emission Tomography (PET) imaging. Scan coverage will extend from the vertex to the mid-thighs and in certain circumstances, coverage may be extended to the toes. Imaging will be acquired 20-28 hours after I-124 administered. Participants will be followed up for any adverse events for up to 5 days after the scan has been completed. |
| Name | Type | Description |
|---|---|---|
| Iodine-124 | DRUG | Given Orally |
| Positron Emission Tomography (PET)/Computerized tomography (CT) | PROCEDURE | Combination of PET and CT imaging |
Inclusion Criteria: 1. Age \>= 13 years. 2. Histopathologically confirmed differentiated or poorly differentiated thyroid cancer. 3. Meeting criteria for one of the following two populations: 1. American Thyroid Association (ATA) intermediate or high-risk thyroid cancer and planning on treatmen...
Iodine-124 is an investigational small molecule being studied for use in thyroid cancer. It is a radioactive isotope used in positron emission tomography (PET) imaging to help diagnose the disease. The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.
Iodine-124 is a radioactive isotope of iodine that is taken up by thyroid tissue, including thyroid cancer cells, due to their natural iodine uptake mechanism. This allows it to be used as a tracer in PET imaging to visualize and diagnose thyroid cancer. It does not target a specific molecular receptor or protein.
Iodine-124 is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's use in diagnosing thyroid cancer.
Iodine-124 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval and is still being studied in clinical trials. The ongoing Phase 2 trial is actively recruiting participants.
Iodine-124 is being studied in a Phase 2 clinical trial with the identifier NCT06961084, titled 'Comparison of I-124 PET/CT for the Diagnosis of Thyroid Cancer.' This trial is recruiting 62 participants in the United States and is not randomized or blinded. The trial is open to individuals aged 13 years and older.
Yes, Iodine-124 is commonly referred to as I-124. The clinical trial NCT06961084 uses the abbreviation 'I-124' in its title to refer to the same drug. This shorthand is frequently used in medical literature and trial documentation.