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Pilot Prospective Study for PET-CT Imaging in Participants With Relapsed/Refractory Acute Leukemias
Sponsor: National Cancer Institute (NCI)
Summary
Background Acute lymphoblastic leukemia (ALL) accounts for about 25 percent of childhood cancers and for about 20 percent of adult leukemias. The disease can be treated with CAR T-cell infusion but non-central nervous system (CNS) extramedullary disease (EMD) is associated with lower rates of complete remission. 18-fludeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) has been shown to be effective for detection of non-CNS EMD in ALL. Pre and post CAR T-cell infusion may help to predict outcomes and risk of early progression. Objectives To describe the number of adults with relapsed/refractory B-cell ALL who proceed to CAR T-cell therapy. Eligibility Participants \>=18 years with relapsed/refractory B-cell ALL who are being screened for CAR T-cell clinical trial enrollment, and Participants \<18 with relapsed/refractory B cell ALL who are being screened for CAR T-cell clinical trial enrollment and have a clinical indication for FDG PET-CT prior to CAR infusion. Design Pilot study to add screening FDG PET-CT as part of the pre-CAR T-cell baseline evaluation with additional imaging at day 28 and future timepoints pending evidence of non-CNS EMD on initial scan.
Key Details
Gender
All
Age Range
5 Years - 39 Years
Study Type
OBSERVATIONAL
Enrollment
10
Start Date
2023-08-25
Completion Date
2025-12-01
Last Updated
2026-04-20
Healthy Volunteers
No
Locations (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, United States