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PUMA (Paediatric Osseous Marrow Assessment) (PUMA)

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ClinicalTrials.gov Identifier: NCT03466944
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Nandita deSouza, Institute of Cancer Research, United Kingdom

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.


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 Patients unable to tolerate lying flat for this length of time or to tolerate the scan for any reason will be withdrawn from the study.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


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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Correlation between ADC change and white blood cell count [ Time Frame: 8 months ]
  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466944


Contacts
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Contact: Nandita deSouza, Professor 0208 661 3289 nandita.desouza@icr.ac.uk
Contact: Katherine May, BSc 0208 642 6011 ext 4109 katherine.may@rmh.nhs.uk

Locations
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United Kingdom
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    nandita.desouza@icr.ac.uk   
Contact: Katherine May, BSc    0208 661 3340    katherine.may@rmh.nhs.uk   
Principal Investigator: Nandita deSouza, Professor         
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
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Principal Investigator: Nandita deSouza, Professor ICR

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Responsible Party: Nandita deSouza, Professor Nandita DeSouza, Principle Investigator (Joint Head of Unit, Radiotherapy & Imaging), Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT03466944     History of Changes
Other Study ID Numbers: 18/SW/0021 CCR 4779
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nandita deSouza, Institute of Cancer Research, United Kingdom:
Magnetic Resonance Imaging (MRI)
Leukaemia
Whole-Body DiffusionWeighted-Magnetic Resonance Imaging (WB DW-MRI)
Paediatrics

Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms