PUMA - Paediatric OsseoUs Marrow Assessment - study
Research type
Research Study
Full title
Quantitative MRI of bone marrow in a paediatric population
IRAS ID
226967
Contact name
Nandita deSouza
Contact email
Sponsor organisation
Institute of Cancer Research
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
The aims of this pilot study investigating the quantitative magnetic resonance imaging of bone marrow in a paediatric population with leukaemia are:\n- To establish whether ADC of bone marrow after transplantation at the point of engraftment (as defined by peripheral blood white cell count) increases above previously established limits of agreements (reproducibility).\n- To define the range of ADC change in patients with successful engraftment of paediatric bone marrow. \nThis is single centre study assessing biomarker change post bone marrow transplant.\nThe main eligibility criteria include: inpatients with proven acute lymphoblastic or myeloblastic leukaemia planned for bone marrow transplantation, cooperative paediatric individuals and young adults (5-24-years-old) not requiring general anaesthesia or sedation for the purpose of MRI and able to lie flat throughout the scan. \nThe treatment is bone marrow transplant as per standard patient care, without change for trial purposes.\nThe primary endpoint is to assess the percentage of children who achieve a change in ADC of their bone marrow with engraftment that is greater than previously established limits of agreement (reproducibility) of the measurement.\nThe secondary endpoints are to evaluate the heterogeneity of ADC distribution within lumbar spine & pelvis before and after engraftment, the correlation between ADC change and white blood cell count and the comparison of baseline ADC between patients with treated ALL and treated AML.\n\n\n\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0021
Date of REC Opinion
21 Feb 2018
REC opinion
Further Information Favourable Opinion