PUMA (Paediatric Osseous Marrow Assessment)

NCT03466944 | Recruiting

• 1 other identifier: 18/SW/0021 CCR 4779
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukaemia

Keywords

Magnetic Resonance Imaging (MRI); Leukaemia; Whole-Body DiffusionWeighted-Magnetic Resonance Imaging (WB DW-MRI); Paediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Heterogeneity of ADC distribution within lumbar spine & pelvis before and after engraftment, evaluated as the mean ADC.

  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

  8 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 5 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• All patients with relapsed or high risk acute lymphoblastic or myeloblastic leukaemia planned for haemopoietic stem cell transplantation
• Cooperative paediatric individuals and young adults (5-24-years-old) not requiring general anaesthesia or sedation for the purpose of MRI
• Able to lie flat throughout the scan

You may not qualify if:

• Non cooperative patients
• Ferromagnetic implants, contraindicating MRI
• Claustrophobia
• Unable to lie flat throughout the scan
• Uncertain histological diagnosis
• Musculoskeletal disorders
• Metabolic disorders
• Lack of signed parental consent and patient's verbal approval

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

The Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Nandita deSouza, Professor

  ICR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nandita deSouza, Professor

CONTACT

0208 661 3289; nandita.desouza@icr.ac.uk

Katherine May, BSc

CONTACT

0208 642 6011; katherine.may@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Nandita DeSouza, Principle Investigator (Joint Head of Unit, Radiotherapy & Imaging)

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 15, 2018
• Study Start: March 5, 2018
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

GB (1)