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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
110
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.
Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology
Moscow, Russia
RECRUITINGpercentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
Time frame: Before the start of therapy
percentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
Time frame: 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.
Time frame: 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.
Time frame: ap to 1 week After confirmation of remission status, optionally provided.
T1 maping
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
apparent diffusion coefficient
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
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percentage of the water myelin fraction
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
value of the cerebral blood flow
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