PUMA (Paediatric Osseous Marrow Assessment) (PUMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03466944|
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 16, 2018
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.
|Condition or disease|
This is a single-center pilot study. The investigators intend to image 12 inpatients, aged 5-24 years old who are scheduled for haemopoietic stem cell transplantation.
Patients will have two MRI scans requiring them to lie in the scanner for approximately 15 minutes. Patients unable to tolerate lying flat for this length of time or to tolerate the scan for any reason will be withdrawn from the study. If required a play specialist can be organised to help the young patients feel more at ease in the MRI department. MRI does not involve radiation exposure and when performed within national safety guidelines do not pose a significant risk. Patients with contraindications to MRI such as pacemakers, certain metal implants and claustrophobia will not be recruited. Every effort will be made to book scan appointments to coincide with clinic visits.
Scans will be reported as per clinical procedures and data will be made available to the referring consultants immediately via the radiology picture archiving and communications system (PACS).
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|Official Title:||Quantitative Magnetic Resonance Imaging of Bone Marrow in a Paediatric Population With Leukaemia (PUMA)|
|Actual Study Start Date :||March 5, 2018|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||November 30, 2018|
5-24 year old paediatric patients with childhood Leukaemia
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.
- The change in ADC following bone marrow transplantation at the point of engraftment in paediatric patients with leukaemia. [ Time Frame: 8 months ]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.
- Heterogeneity of ADC distribution within lumbar spine & pelvis before and after engraftment, evaluated as the mean ADC. [ Time Frame: 8 months ]This will be evaluated for each patient in each scan (mean ADC for each Region Of Interest) and summarised with histograms and descriptive statistics.
- Correlation between ADC change and white blood cell count [ Time Frame: 8 months ]
- Comparison of baseline ADC between patients with treated ALL and treated AML [ Time Frame: 8 months ]A baseline magnetic resonance scan with diffusion-weighted images and without contrast administration will be performed at the end of the neoadjuvant treatment (chemotherapy with/without radiation depending on the type of leukaemia).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466944
|Contact: Nandita deSouza, Professor||0208 661 firstname.lastname@example.org|
|Contact: Katherine May, BSc||0208 642 6011 ext email@example.com|
|The Institute of Cancer Research and Royal Marsden NHS Foundation Trust||Recruiting|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Contact: Nandita deSouza, Professor 0208 661 3289 firstname.lastname@example.org|
|Contact: Katherine May, BSc 0208 661 3340 email@example.com|
|Principal Investigator: Nandita deSouza, Professor|
|Principal Investigator:||Nandita deSouza, Professor||ICR|