Quantitative MRI of Bone Marrow Fat Fraction in Patients With Trepanobiopsy

Aplastic Anemia Clinical Trial

Official title:

Clinical Study of the Sensitivity and Specificity of the Quantitative Assessment of Bone Marrow Cellularity by MRI in Comparison With Trepanobiopsies in Patients With Diseases of the Hematopoietic System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04761965
• Other study ID #: NCPHOI-2019-06
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: January 1, 2024

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2024
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Aplastic Anemia
• Aplastic Anemia Idiopathic

Intervention

Diagnostic Test:
• Bone marrow cellularity by mDixon-quant
if trepanobiopsy was performed during the diagnosis, then comparison with MRI Bone marrow cellularity by mDixon-quant

Locations

Country	Name	City	State
Russian Federation	Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology	Moscow	Samory-Mashela,1

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	correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy.	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.	Before the start of treatment
Secondary	T1 maping	T1 mapping (ms) is a magnetic resonance imaging technique used to calculate the T1 time	Before the start of treatment
Secondary	apparent diffusion coefficient	value of apparent diffusion coefficient in mm2/s	Before the start of treatment
Secondary	Percentage of the macromolecular proton fraction (MPF)	Percentage of the macromolecular proton fraction (MPF)	Before the start of treatment
Secondary	Percentage of the bone marrow fat fraction	Percentage of the bone marrow fat fraction (FF) by spectroscopy	Before the start of treatment