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 |
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Leukaemia |
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 Patients unable to tolerate lying flat for this length of time or to tolerate the scan for any reason will be withdrawn from the study.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 |
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 : | May 2022 |
Estimated Study Completion Date : | May 2022 |
Group/Cohort |
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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.
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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 |
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.
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Nandita deSouza, Professor | ICR |
Tracking Information | |||||||||
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First Submitted Date | March 8, 2018 | ||||||||
First Posted Date | March 15, 2018 | ||||||||
Last Update Posted Date | March 5, 2021 | ||||||||
Actual Study Start Date | March 5, 2018 | ||||||||
Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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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. |
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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 | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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. |
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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.
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
12 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | May 2022 | ||||||||
Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 5 Years to 24 Years (Child, Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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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 |
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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 |
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PRS Account | Institute of Cancer Research, United Kingdom | ||||||||
Verification Date | March 2021 |