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Quantitative MRI of Bone Marrow Fat Fraction in Patients With Trepanobiopsy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04761965
Enrollment
150
Registered
2021-02-21
Start date
2021-02-16
Completion date
2024-01-01
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

Aplastic Anemia, Aplastic Anemia Idiopathic

Keywords

Quantitative MRI, trepanobiopsy, Aplastic Anemia Idiopathic, children

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.

Interventions

DIAGNOSTIC_TESTBone marrow cellularity by mDixon-quant

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy.Before the start of treatmentDetermination 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

MeasureTime frameDescription
T1 mapingBefore the start of treatmentT1 mapping (ms) is a magnetic resonance imaging technique used to calculate the T1 time
apparent diffusion coefficientBefore the start of treatmentvalue of apparent diffusion coefficient in mm2/s
Percentage of the macromolecular proton fraction (MPF)Before the start of treatmentPercentage of the macromolecular proton fraction (MPF)
Percentage of the bone marrow fat fractionBefore the start of treatmentPercentage of the bone marrow fat fraction (FF) by spectroscopy

Countries

Russia

Contacts

Primary ContactNataliia Kriventsova
nataliya.krivencova@fccho-moscow.ru+7 (495)2876570

Outcome results

None listed

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