NCT04761965

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

February 15, 2021

Last Update Submit

March 7, 2023

Conditions

Aplastic AnemiaAplastic Anemia Idiopathic

Keywords

Quantitative MRItrepanobiopsyAplastic Anemia Idiopathicchildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • T1 maping

    Before the start of treatment

  • apparent diffusion coefficient

    Before the start of treatment

  • Percentage of the macromolecular proton fraction (MPF)

    Before the start of treatment

  • Percentage of the bone marrow fat fraction

    Before the start of treatment

Interventions

Bone marrow cellularity by mDixon-quantDIAGNOSTIC_TEST

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

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • presence of indications for performing trepanobiopsy:
  • aplastic anemia
  • chronic myeloproliferative disease
  • reactive changes in hematopoiesis

You may not qualify if:

  • Refusal to sign an informed consent to participate in a clinical trial
  • Presence of contraindications for MRI examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, Samory-Mashela,1, 11198, Russia

RECRUITING

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow Diseases

Central Study Contacts

Nataliia Kriventsova

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 21, 2021

Study Start

February 16, 2021

Primary Completion

December 26, 2023

Study Completion

January 1, 2024

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)