Evaluation of Brain Changes in ALL Patients on Therapy

NCT ID: NCT04767152

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-16

Study Completion Date

2026-01-21

Brief Summary

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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.

Detailed Description

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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

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Acute Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal Research Institute of Pediatric Hematology, Oncology and Immunology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Nataliia f Kriventsova

Role: CONTACT

+7 (495)2876570 ext. 4508

Facility Contacts

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Dmitry Balashov, MD, PhD

Role: primary

+7(495)287-6570 ext. 6534

Michael Maschan, Professor

Role: backup

Other Identifiers

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NCPHOI-2019-07

Identifier Type: -

Identifier Source: org_study_id

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