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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04767165
Other study ID # NCPHOI-2019-10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2021
Est. completion date March 21, 2026

Study information

Verified date March 2023
Source Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Contact Nataliia Kriventsova
Phone +7 (495)2876570
Email nataliya.krivencova@fccho-moscow.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date March 21, 2026
Est. primary completion date March 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Russian Federation Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology Moscow

Sponsors (1)

Lead Sponsor Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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