Clinical trial · Interventional
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
Multi-Modality Imaging and Correlative Studies in Patients With Leukemia
NCT03422731CI-TRIAL-00113942active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial investigates multi-modality imaging and collection of biospecimen samples in understanding bone marrow changes in patients with acute myeloid leukemia undergoing total body irradiation (TBI) and chemotherapy. Using multi-modality imaging and collecting biospecimen samples may help doctors know more about how TBI and chemotherapy can change the bone marrow.
Conditions
Conditions (2)
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 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dual-Energy Computed Tomography | Procedure | — | UNRESOLVED |
| Fluorothymidine F-18 | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort I (TMLI+FLT/TMLI)
- description
- Patients may undergo optional fluorothymidine F-18 PET scan over 2 hours at baseline, on days 30 and 100, at 1 year, and at time of relapse. Patients undergo DECT and water-fat MRI scan over 30 minutes at baseline, on days 30 and 100, at year 1, and at time of relapse. Patients also undergo collection of bone marrow and blood samples at baseline, on days 30 and 100, and at 1 year. Patients undergo fluorothymidine F-18 PET, DECT, and water-fat MRI as in TMLI+FLT.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Dual-Energy Computed Tomography
- Drug: Fluorothymidine F-18
- Other: Laboratory Biomarker Analysis
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- type
- ACTIVE_COMPARATOR
- label
- Cohort II (TBI)
- description
- Patients undergo collection of bone marrow at baseline, day 30, time of relapse, and at 1 year.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cohort TMLI+FLT: AML patients eligible for and enrolling on COH 14012 or IRB 17505 that agree to participate in optional FLT PET imaging * Note: patients enrolling on IRB 19518 cannot enroll onto this cohort, but they may enroll on Cohort TMLI (below) * Cohort TMLI: AML or ALL patients eligible for and enrolling on COH 14012, IRB 17505 or IRB 19518 * Cohort TBI: First or second remission AML or ALL patients that will receive TBI (13.2 Gy) plus chemotherapy (etoposide \[VP16\] 60 mg/kg or cyclophosphamide \[Cy\] 60 mg/kg for two days) as part of their standard of care * Cohort TBI: Documented written informed consent of participant * Cohort TBI: Age \>= 18 to =\< 60 years * Cohort TBI: Patients who have not received a prior transplant
References
Publications (1)
- DERIVEDMalekzadeh M, Ghimire H, Popuri K, Fujita K, Salhotra A, Yamauchi D, Chen B, Froelich J, Storme G, Stein A, Beg MF, Wong J, Malki MMA, Hui SK. AI-Driven Bone and Marrow Segmentation on FLT-PET/CT: Technical Multi-organ Validation in AML and HCT. Res Sq [Preprint]. 2026 Apr 19:rs.3.rs-9077609. doi: 10.21203/rs.3.rs-9077609/v1. PMID 42040934