Acute Leukemia
Conditions
Keywords
Quantitative MRI, acute lymphoblastic leukemia, neurotoxity, children
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.
Interventions
DIAGNOSTIC_TESTMRI
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.
Sponsors
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. patients from 6 to 18 years old 2. diagnosis of acute lymphoblastic leukemia during chemotherapy
Exclusion criteria
1. patients less then 6, and older then 18 years old 2. patients who cannot perform the study MRI without general anesthesia 3. Refusal to sign informed consent. 4. The presence of absolute contraindications to MRI studies. 5. Extremely serious condition of the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of the macromolecular proton fraction (MPF) in brain tissue. | Before the start of therapy | macromolecular proton fraction (MPF) in brain tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T1 maping | 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 | T1 mapping (ms) is a magnetic resonance imaging technique used to calculate at 4 time points |
| apparent diffusion coefficient | 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 apparent diffusion coefficient in mm2/s calculated at 4 time points |
| percentage of the water myelin fraction | 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 | water myelin fraction calculated at 4 time points |
| value of the cerebral blood flow | 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 | cerebral blood flow (CBF) (ml/100g/min) in brain tissue. calculated at 4 time points |
Countries
Russia
Contacts
Primary ContactNataliia f Kriventsova
Outcome results
None listed