Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia

Not Applicable

Recruiting

• Conditions: Acute Leukemia

• Registration Number: NCT04767165
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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.

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-20
• Study Start: 2021-02-22
• Study First Posted: 2021-02-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
T1 maping (ms)	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
apparent diffusion coefficient (mm2/s)	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).
bone marrow fat fraction (FF) by spectroscopy (%)	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
The macromolecular proton fraction (MPF)	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.

Trial Locations

Locations (1)

Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology; 🇷🇺 Moscow, Russian Federation