Clinical trial · Observational
Pilot Prospective Study for PET-CT Imaging in Participants With Relapsed/Refractory Acute Leukemias
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| B Cell | — | UNRESOLVED | — |
| Relapsed/Refractory | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Adult
- description
- Participants \>/=18 years old with relapsed/refractory B cell ALL proceeding to CAR therapy at the NIH
- label
- Pediatric
- description
- Participants \<18 proceeding to CAR therapy at the NIH with a clinical indication for FDG PET-CT prior to CAR infusion
Primary outcomes (1)
- measure
- Proportion of non-CNS EMD in adult participants with relapsed/refractory B-ALL proceeding to CAR T-cell therapy
- timeFrame
- 3 months
- description
- Estimate the fraction of adult participants who are PET positive for non-CNS EMD
Secondary outcomes (2)
- measure
- Identify risk factors associated with presence of non-CNS EMD pre-CAR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 39 Years
Show eligibility criteria text
* 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.
EXCLUSION CRITERIA:
* Pregnant individuals are excluded from this study
* 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)References
Publications (0)
Data not yet available