NCT04767152

Evaluation of Brain Changes in ALL Patients on Therapy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-16
• Primary completion: 2026-01-01
• Completion: 2026-01-21
• First posted: 2021-02-23
• Last updated: 2023-10-30

Locations

1 site across 1 country: Russia