Evaluation of Brain Changes in ALL Patients on Therapy

Not Applicable

Recruiting

• Conditions: Acute Leukemia

• Registration Number: NCT04767152
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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.

Study Timeline

• Study Start: 2021-02-16
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-20
• Study First Posted: 2021-02-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. patients from 6 to 18 years old
2. diagnosis of acute lymphoblastic leukemia during chemotherapy

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
percentage of the macromolecular proton fraction (MPF) in brain tissue.	ap to 1 week After confirmation of remission status, optionally provided.	macromolecular proton fraction (MPF) in brain tissue.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology; 🇷🇺 Moscow, Russian Federation