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Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT04767165
Recruitment Status : Not yet recruiting
First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Study Description
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Brief Summary:
The study is aimed at assessing changes in the bone marrow of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy. Patients of the same age without hematological diseases will be recruited as a control group.

Condition or disease Intervention/treatment Phase
Acute Leukemia Diagnostic Test: MRI Not Applicable

Detailed Description:

The ratio of fat to water in the bone marrow depends on the cellularity of the bone marrow. In addition to the water/fat ratio in bone marrow there are also other parameters for quantitative MRI assessment. These include the apparent diffusion coefficient (ACD), the T1 relaxation time, mapping of the macromolecular proton fraction. The undoubted advantage of MRI is its non-invasiveness and the ability to assess any localization of the bone marrow.

MRI may become a new non-invasive method for assessing the ratio of fat to cells in the bone marrow in children with hematological malignancies, which can help in making a diagnosis and monitoring the response to therapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Pilot Study of Quantitative MRI Assessment of Bone Marrow in Patients With Acute Lymphoblastic Leukemia and Patients Without Hematopoietic Disorders, From 6 to 18 Years Old
Estimated Study Start Date : February 16, 2021
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 21, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Diagnostic Test: MRI
    Dynamics of Bone marrow fat fraction by mDixon-quant (%)

Outcome Measures
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Primary Outcome Measures :
  1. Dynamics of Bone marrow fat fraction [ Time Frame: Point 1. Before the start of therapy - the starting point. ]
    Dynamics of Bone marrow fat fraction by mDixon-quant (%)

  2. Dynamics of Bone marrow fat fraction [ Time Frame: Point 2. 15 ± 3 days after the start of the therapy. ]
    Dynamics of Bone marrow fat fraction by mDixon-quant (%)

  3. Dynamics of Bone marrow fat fraction [ Time Frame: Point 3. 36 ± 3 days after the start of the therapy. ]
    Dynamics of Bone marrow fat fraction by mDixon-quant (%)

  4. Dynamics of Bone marrow fat fraction [ Time Frame: Point 4. through study completion, an average of 2 year ]
    Dynamics of Bone marrow fat fraction by mDixon-quant (%)


Secondary Outcome Measures :
  1. T1 maping (ms) [ Time Frame: Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year ]
    T1 mapping is a magnetic resonance imaging technique used to calculate the T1 time

  2. apparent diffusion coefficient (mm2/s) [ Time Frame: Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year ]
    Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue, and is commonly clinically calculated using MRI with diffusion-weighted imaging (DWI).

  3. bone marrow fat fraction (FF) by spectroscopy (%) [ Time Frame: Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year ]
    Fat fraction (FF)-this is the ratio of unconfounded fat signal to the sum of the unconfounded fat and water signals

  4. The macromolecular proton fraction (MPF) [ Time Frame: Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year ]
    The macromolecular proton fraction (MPF) is a quantitative MRI parameter determining the magnetization transfer (MT) effect in tissues, and is defined as the relative amount of immobile macromolecular protons involved in magnetization exchange with mobile water protons.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. patients from 6 to 18 years old
  2. diagnosis of acute lymphoblastic leukemia during chemotherapy
  3. patients of the same age without hematological diseases

Exclusion Criteria:

  1. patients less then 6, and older then 18 years old
  2. patients who cannot perform the study MRI without general anesthesia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04767165


Contacts
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Contact: Nataliia Kriventsova +7 (495)2876570 ext 4508 nataliya.krivencova@fccho-moscow.ru
Contact: Galina f Tereshchenko +7 (495)2876570 ext 1220 Galina.Tereshenko@fccho-moscow.ru

Sponsors and Collaborators
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
More Information
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Responsible Party: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
ClinicalTrials.gov Identifier: NCT04767165    
Other Study ID Numbers: NCPHOI-2019-10
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federal Research Institute of Pediatric Hematology, Oncology and Immunology:
Quantitative MRI
acute lymphoblastic leukemia
bone marrow
children
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases