Evaluation of Brain Changes in ALL Patients on Therapy
Primary Purpose
Acute Leukemia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
Sponsored by

About this trial
This is an interventional diagnostic trial for Acute Leukemia focused on measuring Quantitative MRI, acute lymphoblastic leukemia, neurotoxity, children
Eligibility Criteria
Inclusion Criteria:
- patients from 6 to 18 years old
- diagnosis of acute lymphoblastic leukemia during chemotherapy
Exclusion Criteria:
- patients less then 6, and older then 18 years old
- patients who cannot perform the study MRI without general anesthesia
- Refusal to sign informed consent.
- The presence of absolute contraindications to MRI studies.
- Extremely serious condition of the patient.
Sites / Locations
Outcomes
Primary Outcome Measures
percentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
percentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
percentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
percentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
Secondary Outcome Measures
T1 maping
T1 mapping (ms) is a magnetic resonance imaging technique used to calculate at 4 time points
apparent diffusion coefficient
value of apparent diffusion coefficient in mm2/s calculated at 4 time points
percentage of the water myelin fraction
water myelin fraction calculated at 4 time points
value of the cerebral blood flow
cerebral blood flow (CBF) (ml/100g/min) in brain tissue. calculated at 4 time points
Full Information
NCT ID
NCT04767152
First Posted
February 16, 2021
Last Updated
February 25, 2021
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
1. Study Identification
Unique Protocol Identification Number
NCT04767152
Brief Title
Evaluation of Brain Changes in ALL Patients on Therapy
Official Title
Clinical Study of the Therapy Neurotoxicity Using Quantitative Assessment of the Brain Structures and Functions by MRI, EEG and Evoked Potentials in Patients With Acute Lymphoblastic Leukemia Over 6 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 16, 2021 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 21, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is aimed at assessing changes in the brain of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy.
Detailed Description
Children with acute lymphoblastic leukemia receive long-term combined chemotherapy treatment, one of the main part of this treatment is methotrexate. Methotrexate can cause acute, subacute, and long-term neurotoxicity. Clinical symptoms of neurotoxicity, such as seizures, aphasia, are often associated with leukoencephalopathy. However, leukoencephalopathy may develop asymptomatically in children receiving methotrexate.
The effect of chemotherapy on the neurological status of patients is widely covered in the literature. There are very few studies devoted to the quantitative assessment of MRI parameters, especially in children. MRI is a non-invasive method that does not harm the patient and can be used to assess absolutely all structures of the brain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia
Keywords
Quantitative MRI, acute lymphoblastic leukemia, neurotoxity, children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
The quantitative assessment of MRI parameters, The macromolecular proton fraction (MPF) (%) in brain tissue. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. After completing three courses of consolidation chemotherapy. Point 4. After confirmation of remission status, optionally provided.
Primary Outcome Measure Information:
Title
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Description
macromolecular proton fraction (MPF) in brain tissue.
Time Frame
Before the start of therapy
Title
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Description
macromolecular proton fraction (MPF) in brain tissue.
Time Frame
36 ± 3 days after the start of the therapy..
Title
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Description
macromolecular proton fraction (MPF) in brain tissue.
Time Frame
ap to 1 week After completing three courses of consolidation chemotherapy.
Title
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Description
macromolecular proton fraction (MPF) in brain tissue.
Time Frame
ap to 1 week After confirmation of remission status, optionally provided.
Secondary Outcome Measure Information:
Title
T1 maping
Description
T1 mapping (ms) is a magnetic resonance imaging technique used to calculate at 4 time points
Time Frame
Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
Title
apparent diffusion coefficient
Description
value of apparent diffusion coefficient in mm2/s calculated at 4 time points
Time Frame
Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
Title
percentage of the water myelin fraction
Description
water myelin fraction calculated at 4 time points
Time Frame
Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
Title
value of the cerebral blood flow
Description
cerebral blood flow (CBF) (ml/100g/min) in brain tissue. calculated at 4 time points
Time Frame
Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients from 6 to 18 years old
diagnosis of acute lymphoblastic leukemia during chemotherapy
Exclusion Criteria:
patients less then 6, and older then 18 years old
patients who cannot perform the study MRI without general anesthesia
Refusal to sign informed consent.
The presence of absolute contraindications to MRI studies.
Extremely serious condition of the patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nataliia f Kriventsova
Phone
+7 (495)2876570
Ext
4508
Email
nataliya.krivencova@fccho-moscow.ru
12. IPD Sharing Statement
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Evaluation of Brain Changes in ALL Patients on Therapy
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