Assessing bone marrow engraftment in young leukaemia patients using MRI
Quantitative Magnetic Resonance Imaging of Bone Marrow in a Paediatric Population With Leukaemia (PUMA)
This study is testing how well bone marrow from a transplant works in young leukemia patients by using MRI scans before and a few weeks after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 5 Years to 24 Years |
| Sex | All |
| Sponsor | Institute of Cancer Research, United Kingdom Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sutton, Surrey) |
| Trial ID | NCT03466944 on ClinicalTrials.gov |
What this trial studies
This pilot observational study aims to evaluate the engraftment of bone marrow in paediatric patients with leukaemia following haemopoietic stem cell transplantation. It involves performing functional Magnetic Resonance Imaging (MRI) of the lumbar spine and pelvis at baseline and 2-3 weeks post-transplantation to measure changes in the apparent diffusion coefficient (ADC). The study will include 12 patients aged 5-24 years who are scheduled for transplantation, with the goal of enhancing understanding of bone marrow features on imaging and improving patient management. MRI scans will be conducted without radiation exposure, and results will be shared with referring consultants immediately.
Who should consider this trial
Good fit: Ideal candidates are cooperative paediatric patients aged 5-24 years with relapsed or high-risk acute leukaemia scheduled for stem cell transplantation.
Not a fit: Patients with contraindications to MRI, such as ferromagnetic implants or claustrophobia, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for assessing successful clinical outcomes in young leukaemia patients post-transplantation.
How similar studies have performed: While this approach is novel in its specific application to paediatric leukaemia, similar imaging techniques have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sutton, Surrey
- The Institute of Cancer Research and Royal Marsden NHS Foundation Trust — Sutton, Surrey, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nandita deSouza, Professor — Icr
- Study coordinator: Nandita deSouza, Professor
- Email: nandita.desouza@icr.ac.uk
- Phone: 0208 661 3289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.