This phase II trial evaluates whether an investigational scan (I-124 positron emission tomography [PET]/computed tomography [CT]) is just as effective as the standard imaging technique (I-123 single photon emission computed tomography [SPECT]/CT) for determining whether thyroid cancer has spread from where it first started (primary site) to other places in the body (metastasized). I-124 is a radioactive isotope of iodine that selectively accumulates in thyroid tissue. I-124 emits positrons that can be detected by PET/CT, allowing visualization of thyroid tissue. A PET scan is a procedure in which a small amount of a radioactive agent is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the agent is taken up. Because the agent used in this study (I-124) is taken up selectively by thyroid tissue, the pictures can be used to find thyroid tumor tissue in the body. CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The new I-124 PET/CT technique may be just as effective as the standard I-123 SPECT/CT technique for determining whether or not a patient's thyroid cancer has metastasized.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06961084.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Thomas A. Hope
Phone: 415-221-4810ext22648
PRIMARY OBJECTIVE:
I. Agreement between iodine I 124 (I-124) PET and iodine I-123 (I-123)/iodine I-131 (I-131) SPECT.
SECONDARY OBJECTIVES:
I. Sensitivity and specificity of I-124 PET to detect metastatic thyroid cancer compared to composite truth standard.
II. Reclassification rate of I-124 PET compared to I-123 SPECT.
III. To determine the inter-reader variability for I-124 PET and I-123 SPECT.
IV. To determine the safety and tolerability of I-124 in participants with thyroid cancer as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
V. Participant level detection rate for I-124 in the overall population.
VI. Participant level detection rate for I-124 in participants who have negative I-123 SPECT.
VII. Comparison of lesion detection between I-124 PET and 24 hour I-123 SPECT.
VIII. Comparison of lesion detection between I-124 PET and 7-day post-treatment I-131 SPECT.
EXPLORATORY OBJECTIVES:
I. Ability to predict lesion absorbed dose using I-124 PET/CT.
II. Subset analysis of agreement as well as sensitivity and specificity, breaking patients down between those previously treated with I-131 and those naïve to treatment with I-131.
OUTLINE:
Patients receive I-124 orally (PO) on day 2 and undergo PET/CT 20-28 hours later, on day 3. Patients may undergo an optional PET/CT scan during follow-up, on day 3-6. Patients also undergo I-123 SPECT/CT per standard of care (SOC) on study.
After completion of study intervention, patients are followed up on days 3-5.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorThomas A. Hope
