PUMA (Paediatric Osseous Marrow Assessment)

Leukaemia Clinical Trial

— PUMA  

Official title:

Quantitative Magnetic Resonance Imaging of Bone Marrow in a Paediatric Population With Leukaemia (PUMA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03466944
• Other study ID #: 18/SW/0021 CCR 4779
• Status: Recruiting
• Start date: March 5, 2018
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Institute of Cancer Research, United Kingdom
• Contact: Nandita deSouza, Professor
• Phone: 0208 661 3289
• Email: nandita.desouza[@]icr.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 Patients unable to tolerate lying flat for this length of time or to tolerate the scan for any reason will be withdrawn from the study.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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukaemia
• Leukemia

Locations

Country	Name	City	State
United Kingdom	The Institute of Cancer Research and Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in ADC following bone marrow transplantation at the point of engraftment in paediatric patients with leukaemia.	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.	8 months
Secondary	Heterogeneity of ADC distribution within lumbar spine & pelvis before and after engraftment, evaluated as the mean ADC.	This will be evaluated for each patient in each scan (mean ADC for each Region Of Interest) and summarised with histograms and descriptive statistics.	8 months
Secondary	Correlation between ADC change and white blood cell count		8 months
Secondary	Comparison of baseline ADC between patients with treated ALL and treated AML	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).	8 months