NCT04767165

Brief Summary

The study is aimed at assessing changes in the bone marrow of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy. Patients of the same age without hematological diseases will be recruited as a control group.

Trial Health

57
Monitor

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

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2026

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

5 years

First QC Date

February 16, 2021

Last Update Submit

March 7, 2023

Conditions

Acute Leukemia

Keywords

Quantitative MRIacute lymphoblastic leukemiabone marrowchildren

Outcome Measures

Primary Outcomes (4)

  • Dynamics of Bone marrow fat fraction

    Dynamics of Bone marrow fat fraction by mDixon-quant (%)

    Point 1. Before the start of therapy - the starting point.

  • Dynamics of Bone marrow fat fraction

    Dynamics of Bone marrow fat fraction by mDixon-quant (%)

    Point 2. 15 ± 3 days after the start of the therapy.

  • Dynamics of Bone marrow fat fraction

    Dynamics of Bone marrow fat fraction by mDixon-quant (%)

    Point 3. 36 ± 3 days after the start of the therapy.

  • Dynamics of Bone marrow fat fraction

    Dynamics of Bone marrow fat fraction by mDixon-quant (%)

    Point 4. through study completion, an average of 2 year

Secondary Outcomes (4)

  • T1 maping (ms)

    Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year

  • apparent diffusion coefficient (mm2/s)

    Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year

  • bone marrow fat fraction (FF) by spectroscopy (%)

    Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year

  • The macromolecular proton fraction (MPF)

    Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year

Interventions

MRIDIAGNOSTIC_TEST

Dynamics of Bone marrow fat fraction by mDixon-quant (%)

Eligibility Criteria

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

You may qualify if:

  • patients from 6 to 18 years old
  • diagnosis of acute lymphoblastic leukemia during chemotherapy
  • patients of the same age without hematological diseases

You may not qualify if:

  • patients less then 6, and older then 18 years old
  • patients who cannot perform the study MRI without general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Moscow, 117997, Russia

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Nataliia Kriventsova

CONTACT

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

Galina f Tereshchenko

CONTACT

+7 (495)2876570Galina.Tereshenko@fccho-moscow.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 23, 2021

Study Start

February 22, 2021

Primary Completion

March 1, 2026

Study Completion

March 21, 2026

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)