Evaluation of Brain Changes in ALL Patients on Therapy

Study Overview
=================
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.

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

Conditions
-----------------
Acute Leukemia

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MRI|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of the macromolecular proton fraction (MPF) in brain tissue. | macromolecular proton fraction (MPF) in brain tissue. | Before the start of therapy | 
| percentage of the macromolecular proton fraction (MPF) in brain tissue. | macromolecular proton fraction (MPF) in brain tissue. | 36 ± 3 days after the start of the therapy.. | 
| percentage of the macromolecular proton fraction (MPF) in brain tissue. | macromolecular proton fraction (MPF) in brain tissue. | ap to 1 week After completing three courses of consolidation chemotherapy. | 
| percentage of the macromolecular proton fraction (MPF) in brain tissue. | macromolecular proton fraction (MPF) in brain tissue. | ap to 1 week After confirmation of remission status, optionally provided. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1 maping | T1 mapping (ms) is a magnetic resonance imaging technique used to calculate at 4 time points | 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 | 
| apparent diffusion coefficient | value of apparent diffusion coefficient in mm2/s calculated at 4 time points | 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 | 
| percentage of the water myelin fraction | water myelin fraction calculated at 4 time points | 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 | 
| value of the cerebral blood flow | cerebral blood flow (CBF) (ml/100g/min) in brain tissue. calculated at 4 time points | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quantitative MRI, acute lymphoblastic leukemia, neurotoxity, children