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Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia

Primary Purpose

Acute Leukemia

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
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, bone marrow, children

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and ImmunologyRecruiting

Outcomes

Primary Outcome Measures

Dynamics of Bone marrow fat fraction
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Dynamics of Bone marrow fat fraction
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Dynamics of Bone marrow fat fraction
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Dynamics of Bone marrow fat fraction
Dynamics of Bone marrow fat fraction by mDixon-quant (%)

Secondary Outcome Measures

T1 maping (ms)
T1 mapping is a magnetic resonance imaging technique used to calculate the T1 time
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).
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
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.

Full Information

First Posted
February 16, 2021
Last Updated
March 7, 2023
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
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1. Study Identification

Unique Protocol Identification Number
NCT04767165
Brief Title
Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 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

5. Study Description

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.
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.

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, bone marrow, children

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Primary Outcome Measure Information:
Title
Dynamics of Bone marrow fat fraction
Description
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Time Frame
Point 1. Before the start of therapy - the starting point.
Title
Dynamics of Bone marrow fat fraction
Description
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Time Frame
Point 2. 15 ± 3 days after the start of the therapy.
Title
Dynamics of Bone marrow fat fraction
Description
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Time Frame
Point 3. 36 ± 3 days after the start of the therapy.
Title
Dynamics of Bone marrow fat fraction
Description
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Time Frame
Point 4. through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
T1 maping (ms)
Description
T1 mapping is a magnetic resonance imaging technique used to calculate the T1 time
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
Title
apparent diffusion coefficient (mm2/s)
Description
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).
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
Title
bone marrow fat fraction (FF) by spectroscopy (%)
Description
Fat fraction (FF)-this is the ratio of unconfounded fat signal to the sum of the unconfounded fat and water signals
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
Title
The macromolecular proton fraction (MPF)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nataliia Kriventsova
Phone
+7 (495)2876570
Ext
4508
Email
nataliya.krivencova@fccho-moscow.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Galina f Tereshchenko
Phone
+7 (495)2876570
Ext
1220
Email
Galina.Tereshenko@fccho-moscow.ru
Facility Information:
Facility Name
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Smirnova
Phone
+7(495)2876570
Ext
5551
Email
lena.smirnova@fccho-moscow.ru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia

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