Clinical trial · Interventional
Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Updating protocol and consents
Summary
Brief summary (as posted)
This is a pilot sub-study of patients receiving myeloablative transplant using total body irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The objective of this stub-study is to estimate the heterogeneity in cellular proliferation (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured using whole body water-fat MRI) using positron emission tomography imaging. This will be used to design future trials as well as to determine the feasibility of PET and MRI imaging.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLT PET/CT | Radiation | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging studies
- description
- Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
- interventionNames
- Radiation: FLT PET/CT
- Device: MRI
Primary outcomes (3)
- measure
- Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days
- timeFrame
- 100 days
- description
- The difference in percentage of proliferating bone marrow will be calculated for the following sites: skull, proximal humeri, ribs, clavicles, cervical spine, thoracic spine, lumbar spine, sacrum, pelvis and proximal femur.
- measure
- Difference in Water Fat
- timeFrame
- 100 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of hematologic malignancy and fitting into one of the following categories: * Newly diagnosed and/or day 14 post-induction chemotherapy * Relapsed, including relapse after hematopoietic cell transplant * Planned hematopoietic cell transplant (if enrolling at "close") or within 100 days post hematopoietic cell transplant (if enrolling post-transplant) with a preparative regimen that includes either total marrow irradiation (TMI) or total body irradiation (TBI) * Undergoing natural killer cell therapies (with or without subsequent transplant) * Aged 18 years and older * Not pregnant - women of childbearing potential will have a confirmatory pregnancy test prior to each imaging per routine procedures * Adequate renal function (estimated glomerular filtration rate \> 60 ml/min) as determined by a serum creatinine level performed as a part of standard of care within 7 days of imaging * Able and willing to provide written consent Exclusion Criteria: * Otherwise eligible patients meeting one or more of the contraindicates for an MRI, may enroll in the study without undergoing the MRI: * ferromagnetic implants * history of shrapnel or shot gun injury * too large to fit in the magnet (approximate body mass index ≥ 40) * cardiac pacemakers or other implanted devices that are not MR-compatible * claustrophobia * large tattoos
References
Publications (0)
Data not yet available