LeukaemiaPUMANCT03466944
PUMA (Paediatric Osseous Marrow Assessment)
An observational study of Leukaemia, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 24 years
- Conditions the study is for
- Leukaemia
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2018to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Nandita deSouza, Professor, 0208 661 3289, nandita.desouza@icr.ac.uk
Katherine May, BSc, 0208 661 3340, katherine.may@rmh.nhs.uk
About this study
Official title: 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.
Read the 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).
- Conditions
- Leukaemia
- Keywords
- Magnetic Resonance Imaging (MRI), Leukaemia, Whole-Body DiffusionWeighted-Magnetic Resonance Imaging (WB DW-MRI), Paediatrics
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (3)
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.
Measured: 8 months
Correlation between ADC change and white blood cell count
Measured: 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).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start5 Mar 2018
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
- Investigators
- Nandita deSouza, Professor, Principal investigator, ICR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466944
- Sponsor's protocol ID
- 18/SW/0021 CCR 4779
- Acronym
- PUMA
- Status last verified
- Apr 2024
- First submitted
- 8 Mar 2018
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Magnetic Resonance Imaging of Bone Marrow in a Paediatric Population With Leukaemia (PUMA)
- ClinicalTrials.gov ID
- NCT03466944
- Acronym / sponsor ID
- PUMA / 18/SW/0021 CCR 4779
- Conditions
- Leukaemia
- Keywords
- Magnetic Resonance Imaging (MRI), Leukaemia, Whole-Body DiffusionWeighted-Magnetic Resonance Imaging (WB DW-MRI), Paediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Non cooperative patients
- Ferromagnetic implants, contraindicating MRI
- Claustrophobia
- Unable to lie flat throughout the scan
- Uncertain histological diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Heterogeneity of ADC distribution within lumbar spine & pelvis before and after engraftment, evaluated as the mean ADC.
Time frame: 8 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nandita deSouza, Professor principal investigator
ICR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukaemia, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nandita deSouza, Professor (0208 661 3289, nandita.desouza@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in ADC following bone marrow transplantation at the point of engraftment in paediatric patients with leukaemia. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.