Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia

February 20, 2021 updated by: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Acute Leukemia

Intervention / Treatment

Diagnostic test: MRI

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 Type

Interventional

Enrollment (Anticipated)

150

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

Name: Nataliia Kriventsova
Phone Number: 4508 +7 (495)2876570
Email: nataliya.krivencova@fccho-moscow.ru

Study Contact Backup

Name: Galina f Tereshchenko
Phone Number: 1220 +7 (495)2876570
Email: Galina.Tereshenko@fccho-moscow.ru

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

Yes

Genders Eligible for Study

All

Description

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

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: Non-Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%)	Point 1. Before the start of therapy - the starting point.
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 (%)	Point 2. 15 ± 3 days after the start of the therapy.
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 (%)	Point 3. 36 ± 3 days after the start of the therapy.
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 (%)	Point 4. through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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) 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).	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 (%) 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	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) 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.	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

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 (Anticipated)

February 16, 2021

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

January 21, 2026

Study Registration Dates

First Submitted