Quantitative MRI of Bone Marrow Fat Fraction in Patients With Trepanobiopsy

Not Applicable

Recruiting

• Conditions: Aplastic Anemia; Aplastic Anemia Idiopathic

• Registration Number: NCT04761965
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Brief Summary

The study is aimed to find correlation between the assessment of cellularity according to trepanobiopsy data and the results of measuring MRI parameters.

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 cellularity of the bone marrow in children with oncohematological diseases.

Study Timeline

• Study First Submitted: 2021-02-15
• Study Start: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08
• Primary Completion: 2023-12-26
• Study Completion: 2024-01-01

Recruitment & Eligibility

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

Inclusion Criteria

presence of indications for performing trepanobiopsy:

1. aplastic anemia
2. chronic myeloproliferative disease
3. reactive changes in hematopoiesis

Exclusion Criteria

1. Refusal to sign an informed consent to participate in a clinical trial
2. Presence of contraindications for MRI examination
3. Extremely serious condition of the patient at the time of inclusion in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy.	Before the start of treatment	Determination of bone marrow cellularity before starting therapy for the underlying disease. Cellularity according to trepanobiopsy data is the ratio of stromal and hematopoietic cells to fat cells in the bone marrow. Cellularity according to MRI - the ratio of water and fat in the bone marrow using the mDixom Quant.

Secondary Outcome Measures

Name	Time	Method
Percentage of the bone marrow fat fraction	Before the start of treatment	Percentage of the bone marrow fat fraction (FF) by spectroscopy
Percentage of the macromolecular proton fraction (MPF)	Before the start of treatment	Percentage of the macromolecular proton fraction (MPF)
T1 maping	Before the start of treatment	T1 mapping (ms) is a magnetic resonance imaging technique used to calculate the T1 time
apparent diffusion coefficient	Before the start of treatment	value of apparent diffusion coefficient in mm2/s

Trial Locations

Locations (1)

Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology; 🇷🇺 Moscow, Samory-Mashela,1, Russian Federation