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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

Tracking Information
First Submitted Date March 8, 2018
First Posted Date March 15, 2018
Last Update Posted Date March 16, 2018
Actual Study Start Date March 5, 2018
Estimated Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03466944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 15, 2018)
  • 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).
Original Secondary Outcome Measures
 (submitted: March 14, 2018)
  • 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 ROI) 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PUMA (Paediatric Osseous Marrow Assessment)
Official Title Quantitative Magnetic Resonance Imaging of Bone Marrow in a Paediatric Population With Leukaemia (PUMA)
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Leukaemia
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 14, 2018)
12
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2018
Estimated Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03466944
Other Study ID Numbers 18/SW/0021 CCR 4779
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Nandita deSouza, Institute of Cancer Research, United Kingdom
Study Sponsor Institute of Cancer Research, United Kingdom
Collaborators Not Provided
Investigators
Principal Investigator: Nandita deSouza, Professor ICR
PRS Account Institute of Cancer Research, United Kingdom
Verification Date March 2018