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.
Additional locations may be listed 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
