PUMA (Paediatric Osseous Marrow Assessment) (PUMA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Leukaemia

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 Patients unable to tolerate lying flat for this length of time or to tolerate the scan for any reason will be withdrawn from the study.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

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Nandita deSouza, Professor; Phone Number: 0208 661 3289; Email: nandita.desouza@icr.ac.uk
• Study Contact Backup: Name: Katherine May, BSc; Phone Number: 4109 0208 642 6011; Email: katherine.may@rmh.nhs.uk

Study Locations

• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Recruiting
      • The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
      • Contact: Nandita deSouza, Professor; Phone Number: 0208 661 3289; Email: nandita.desouza@icr.ac.uk
      • Contact: Katherine May, BSc; Phone Number: 0208 661 3340; Email: katherine.may@rmh.nhs.uk
      • Principal Investigator: Nandita deSouza, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A pilot paediatric cohort of 12 patients with Acute lymphoblastic leukaemia (ALL) or Acute myeloid leukemia (AML), aged 5-25 years old, will be studied before and after haemopoietic stem cell transplantation.

Patients with either of the two types of acute leukaemia will be included.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Correlation between ADC change and white blood cell count		8 months
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

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom
• Investigators: Principal Investigator: Nandita deSouza, Professor, ICR

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging (MRI); Paediatrics; Leukaemia; Whole-Body DiffusionWeighted-Magnetic Resonance Imaging (WB DW-MRI)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Leukemia
• Other Study ID Numbers: 18/SW/0021 CCR 4779

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No