Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia

Acute Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04767165
• Other study ID #: NCPHOI-2019-10
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

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