Clinical trial · Observational
PUMA (Paediatric Osseous Marrow Assessment)
Quantitative Magnetic Resonance Imaging of Bone Marrow in a Paediatric Population With Leukaemia (PUMA)
- 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 is a pilot cancer imaging study investigating change in the apparent diffusion coefficient (ADC) at a single time point post-transplantation in patients. The treatment is bone marrow transplant as per standard patient care, without change for trial purposes. Its main aim is to evaluate the engraftment of bone marrow after transplantation performing functional Magnetic Resonance Imaging (MRI) of the lumbar spine and pelvis at baseline and after 2-3 weeks after the transplantation (according to the appearances of raised white blood cells).This will enhance the understanding of bone marrow features on imaging at engraftment and improve the management of children/young adults who suffer acute leukaemia. Following allogenic haemopoietic stem cell transplantation, changes in bone marrow apparent diffusion coefficient (ADC) are measurable at the point of engraftment and in conjunction with peripheral blood counts may provide a future biomarker of successful clinical outcome.
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 |
|---|---|---|---|
| Leukaemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 5-24 year old paediatric patients with childhood Leukaemia
- description
- Cooperative paediatric individuals and young adults (5-24-years-old) with proven Acute Lymphoblastic Leukaemia (ALL) or Acute Myeloblastic Leukaemia (AML) planned for bone marrow transplantation.
Primary outcomes (1)
- measure
- The change in ADC following bone marrow transplantation at the point of engraftment in paediatric patients with leukaemia.
- timeFrame
- 8 months
- description
- Measured as the percentage of children who achieve a change in ADC of their bone marrow with engraftment that is greater than the limits of agreement of repeatability of the measurement, established from previous historical data.
Secondary outcomes (3)
- measure
- Heterogeneity of ADC distribution within lumbar spine & pelvis before and after engraftment, evaluated as the mean ADC.
- timeFrame
- 8 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 24 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients with relapsed or high risk acute lymphoblastic or myeloblastic leukaemia planned for haemopoietic stem cell transplantation 2. Cooperative paediatric individuals and young adults (5-24-years-old) not requiring general anaesthesia or sedation for the purpose of MRI 3. Able to lie flat throughout the scan Exclusion Criteria: 1. Non cooperative patients 2. Ferromagnetic implants, contraindicating MRI 3. Claustrophobia 4. Unable to lie flat throughout the scan 5. Uncertain histological diagnosis 6. Musculoskeletal disorders 7. Metabolic disorders 8. Lack of signed parental consent and patient's verbal approval
References
Publications (0)
Data not yet available