Quantitative MRI of Bone Marrow Fat Fraction in Patients With Trepanobiopsy

February 20, 2021 updated by: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy.
Time Frame: 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.
Before the start of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 16, 2021

Primary Completion (Anticipated)

December 26, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 20, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCPHOI-2019-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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