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Quantitative MRI of Bone Marrow Fat Fraction in Patients With Trepanobiopsy

Primary Purpose

Aplastic Anemia, Aplastic Anemia Idiopathic

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Bone marrow cellularity by mDixon-quant
Sponsored by
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aplastic Anemia focused on measuring Quantitative MRI, trepanobiopsy, Aplastic Anemia Idiopathic, children

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and ImmunologyRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2021
Last Updated
March 7, 2023
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
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1. Study Identification

Unique Protocol Identification Number
NCT04761965
Brief Title
Quantitative MRI of Bone Marrow Fat Fraction in Patients With Trepanobiopsy
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aplastic Anemia, Aplastic Anemia Idiopathic
Keywords
Quantitative MRI, trepanobiopsy, Aplastic Anemia Idiopathic, children

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Bone marrow cellularity by mDixon-quant
Intervention Description
if trepanobiopsy was performed during the diagnosis, then comparison with MRI Bone marrow cellularity by mDixon-quant
Primary Outcome Measure Information:
Title
correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy.
Description
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.
Time Frame
Before the start of treatment
Secondary Outcome Measure Information:
Title
T1 maping
Description
T1 mapping (ms) is a magnetic resonance imaging technique used to calculate the T1 time
Time Frame
Before the start of treatment
Title
apparent diffusion coefficient
Description
value of apparent diffusion coefficient in mm2/s
Time Frame
Before the start of treatment
Title
Percentage of the macromolecular proton fraction (MPF)
Description
Percentage of the macromolecular proton fraction (MPF)
Time Frame
Before the start of treatment
Title
Percentage of the bone marrow fat fraction
Description
Percentage of the bone marrow fat fraction (FF) by spectroscopy
Time Frame
Before the start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presence of indications for performing trepanobiopsy: aplastic anemia chronic myeloproliferative disease reactive changes in hematopoiesis Exclusion Criteria: Refusal to sign an informed consent to participate in a clinical trial Presence of contraindications for MRI examination Extremely serious condition of the patient at the time of inclusion in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nataliia Kriventsova
Phone
+7 (495)2876570
Ext
4508
Email
nataliya.krivencova@fccho-moscow.ru
Facility Information:
Facility Name
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
City
Moscow
State/Province
Samory-Mashela,1
ZIP/Postal Code
11198
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena f Smirnova
Email
lena.smirnova@fccho-moscow.ru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quantitative MRI of Bone Marrow Fat Fraction in Patients With Trepanobiopsy

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