NCT05969002Completed
Pilot Prospective Study for PET-CT Imaging in Participants With Relapsed/Refractory Acute Leukemias
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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....
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 10 (actual)
- First submitted
- 31 Jul 2023
- Start date
- 25 Aug 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- National Cancer Institute (NCI)
- NCT number
- NCT05969002
What you commit to
- Study type: Observational
- Participants enrolled: 10
- From 25 Aug 2023 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study (e.g., FDG injection)
Other
- Pregnant individuals are excluded from this study
Criteria the registry did not label
- INCLUSION CRITERIA:
- Diagnosis: Participants must have a B cell ALL (inclusive of CML with ALL transformation)
- Age: 5-39 years
- All participants \>=18 years old with relapsed/refractory B cell ALL potentially proceeding to CAR therapy at the NIH, or
- Any participant \<18 potentially proceeding to CAR therapy at the NIH with a clinical indication for FDG PET-CT prior to CAR infusion:
- History of prior EMD
- History of post-HSCT relapse
- Clinical signs or incidental findings suspicious for EMD
- Peripheral disease out of proportion of bone marrow disease burden
- Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding within 24 hours of any PET-CT scan
- Ability and willingness of participant or Legally Authorized Representative (LAR) to co-enroll on protocol 10-C-0086 "Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies".
- Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
Age in the registry: 5 years to 39 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.