Evaluation of Brain Changes in ALL Patients on Therapy

October 27, 2023 updated by: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Recruiting
        • Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology
        • Contact:
          • Dmitry Balashov, MD, PhD
          • Phone Number: 6534 +7(495)287-6570
          • Email: bala8@yandex.ru
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time Frame: Before the start of therapy
macromolecular proton fraction (MPF) in brain tissue.
Before the start of therapy
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time Frame: 36 ± 3 days after the start of the therapy..
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.
Time Frame: ap to 1 week After completing three courses of consolidation chemotherapy.
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.
Time Frame: ap to 1 week After confirmation of remission status, optionally provided.
macromolecular proton fraction (MPF) in brain tissue.
ap to 1 week After confirmation of remission status, optionally provided.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T1 maping
Time Frame: 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
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
apparent diffusion coefficient
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2021

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 21, 2026

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 20, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCPHOI-2019-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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