Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Leukemia

Intervention / Treatment
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* Diagnostic Test: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients from 6 to 18 years old diagnosis of acute lymphoblastic leukemia during chemotherapy patients of the same age without hematological diseases Exclusion Criteria: patients less then 6, and older then 18 years old patients who cannot perform the study MRI without general anesthesia

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MRI|Dynamics of Bone marrow fat fraction by mDixon-quant (%)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamics of Bone marrow fat fraction | Dynamics of Bone marrow fat fraction by mDixon-quant (%) | Point 1. Before the start of therapy - the starting point. | 
| Dynamics of Bone marrow fat fraction | Dynamics of Bone marrow fat fraction by mDixon-quant (%) | Point 2. 15 ± 3 days after the start of the therapy. | 
| Dynamics of Bone marrow fat fraction | Dynamics of Bone marrow fat fraction by mDixon-quant (%) | Point 3. 36 ± 3 days after the start of the therapy. | 
| Dynamics of Bone marrow fat fraction | Dynamics of Bone marrow fat fraction by mDixon-quant (%) | Point 4. through study completion, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1 maping (ms) | T1 mapping is a magnetic resonance imaging technique used to calculate the T1 time | 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 (mm2/s) | 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). | 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 | 
| bone marrow fat fraction (FF) by spectroscopy (%) | Fat fraction (FF)-this is the ratio of unconfounded fat signal to the sum of the unconfounded fat and water signals | 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) | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quantitative MRI, acute lymphoblastic leukemia, bone marrow, children