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Evaluation of Brain Changes in ALL Patients on Therapy

Primary Purpose

Acute Leukemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
Sponsored by
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Leukemia focused on measuring Quantitative MRI, acute lymphoblastic leukemia, neurotoxity, children

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    percentage of the macromolecular proton fraction (MPF) in brain tissue.
    macromolecular proton fraction (MPF) in brain tissue.
    percentage of the macromolecular proton fraction (MPF) in brain tissue.
    macromolecular proton fraction (MPF) in brain tissue.
    percentage of the macromolecular proton fraction (MPF) in brain tissue.
    macromolecular proton fraction (MPF) in brain tissue.
    percentage of the macromolecular proton fraction (MPF) in brain tissue.
    macromolecular proton fraction (MPF) in brain tissue.

    Secondary Outcome Measures

    T1 maping
    T1 mapping (ms) is a magnetic resonance imaging technique used to calculate at 4 time points
    apparent diffusion coefficient
    value of apparent diffusion coefficient in mm2/s calculated at 4 time points
    percentage of the water myelin fraction
    water myelin fraction calculated at 4 time points
    value of the cerebral blood flow
    cerebral blood flow (CBF) (ml/100g/min) in brain tissue. calculated at 4 time points

    Full Information

    First Posted
    February 16, 2021
    Last Updated
    February 25, 2021
    Sponsor
    Federal Research Institute of Pediatric Hematology, Oncology and Immunology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04767152
    Brief Title
    Evaluation of Brain Changes in ALL Patients on Therapy
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 16, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2026 (Anticipated)
    Study Completion Date
    January 21, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Federal Research Institute of Pediatric Hematology, Oncology and Immunology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Leukemia
    Keywords
    Quantitative MRI, acute lymphoblastic leukemia, neurotoxity, children

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    MRI
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    percentage of the macromolecular proton fraction (MPF) in brain tissue.
    Description
    macromolecular proton fraction (MPF) in brain tissue.
    Time Frame
    Before the start of therapy
    Title
    percentage of the macromolecular proton fraction (MPF) in brain tissue.
    Description
    macromolecular proton fraction (MPF) in brain tissue.
    Time Frame
    36 ± 3 days after the start of the therapy..
    Title
    percentage of the macromolecular proton fraction (MPF) in brain tissue.
    Description
    macromolecular proton fraction (MPF) in brain tissue.
    Time Frame
    ap to 1 week After completing three courses of consolidation chemotherapy.
    Title
    percentage of the macromolecular proton fraction (MPF) in brain tissue.
    Description
    macromolecular proton fraction (MPF) in brain tissue.
    Time Frame
    ap to 1 week After confirmation of remission status, optionally provided.
    Secondary Outcome Measure Information:
    Title
    T1 maping
    Description
    T1 mapping (ms) is a magnetic resonance imaging technique used to calculate at 4 time points
    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
    Title
    apparent diffusion coefficient
    Description
    value of apparent diffusion coefficient in mm2/s calculated at 4 time points
    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
    Title
    percentage of the water myelin fraction
    Description
    water myelin fraction calculated at 4 time points
    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
    Title
    value of the cerebral blood flow
    Description
    cerebral blood flow (CBF) (ml/100g/min) in brain tissue. calculated at 4 time points
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients from 6 to 18 years old diagnosis of acute lymphoblastic leukemia during chemotherapy Exclusion Criteria: patients less then 6, and older then 18 years old patients who cannot perform the study MRI without general anesthesia Refusal to sign informed consent. The presence of absolute contraindications to MRI studies. Extremely serious condition of the patient.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nataliia f Kriventsova
    Phone
    +7 (495)2876570
    Ext
    4508
    Email
    nataliya.krivencova@fccho-moscow.ru

    12. IPD Sharing Statement

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    Evaluation of Brain Changes in ALL Patients on Therapy

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