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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Diagnostic Test | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nataliia f Kriventsova | Contact | +7 (495)2876570 | 4508 | nataliya.krivencova@fccho-moscow.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology | Recruiting | Moscow | 117997 | Russia |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |