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Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04767165
Enrollment
150
Registered
2021-02-23
Start date
2021-02-22
Completion date
2026-03-21
Last updated
2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia

Keywords

Quantitative MRI, acute lymphoblastic leukemia, bone marrow, children

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.

Interventions

DIAGNOSTIC_TESTMRI

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

Sponsors

Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dynamics of Bone marrow fat fractionPoint 1. Before the start of therapy - the starting point.Dynamics of Bone marrow fat fraction by mDixon-quant (%)

Secondary

MeasureTime frameDescription
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 yearT1 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 yearApparent 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 yearFat 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 yearThe 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.

Countries

Russia

Contacts

Primary ContactNataliia Kriventsova
nataliya.krivencova@fccho-moscow.ru+7 (495)2876570
Backup ContactGalina f Tereshchenko
Galina.Tereshenko@fccho-moscow.ru+7 (495)2876570

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026