NCT04835285

Brief Summary

All patients were investigated using a 3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload quantification in children we have used special sequences for T2\*-mapping. Miocardium, pancreas and pituitary gland T2\* relaxometry maps were calculated automatically by commertial application ReportCARD Functool (GE Healthcare) and integrated Philips T2\* maps. Then for selected ROI T2\* data acquisition in milisecond \[ms\] were performed and calculated automatically.

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
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

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

Study Start

First participant enrolled

January 21, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2023

Completed
Last Updated

April 8, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

March 29, 2021

Last Update Submit

April 5, 2021

Conditions

Iron Overload

Keywords

IronT2* mappingMRI relaxometrytransfusion

Outcome Measures

Primary Outcomes (2)

  • Compare and contrast T2* values in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia using 1.5T and 3T MRI scanner.

    Initially, after one month of chelation therapy

  • Compare and contrast T2* values in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia using 1.5T and 3T MRI scanner.

    up to 1 week after the end of chelation therapy

Secondary Outcomes (3)

  • To calculate the T2* values in the pancreas, myocardium and pituitary gland in patients with transfusion-dependent anemia on the 3T scanner.

    point1: Initially, after one month of chelation therapy; point 2: every week during 1 month for the stability checking point 3: ut to 1 week at the end of the study

  • To develop a control method for iron assessment using aqueous solutions of iron nanoparticles by calculating T2* values on 3T and 1,5T scanners.

    point1: Initially, after one month of chelation therapy; point 2: every week during 1 month for the stability checking point 3: ut to 1 week at the end of the study

  • Draw up T2* values recalculating tables for a 3T scanner based on the distribution of T2* values for a 1.5T scanner in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia.

    point1: Initially, after one month of chelation therapy; point 2: every week during 1 month for the stability checking point 3: ut to 1 week at the end of the study

Interventions

Npf.DIAGNOSTIC_TEST

3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload

Eligibility Criteria

Age6 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age under 25 y.o.;
  • A history of transfusion-dependent anemia of various origins.
  • indications for the appointment of chelation therapy
  • Age over 25 y.o.
  • The number of RBC transfusions previously received by the patient is less than 10

You may not qualify if:

  • Absolute contraindications to magnetic resonance imaging (pacemaker, ferromagnetic implants, etc.);
  • Refusal to sign the informed consent.

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

Iron Overload

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Galina f Tereshchenko, PhD

    Chief radiology department

    STUDY DIRECTOR

Central Study Contacts

Evelina f Nazarova

CONTACT

+79161133945evelina.nazarova@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

March 29, 2021

First Posted

April 8, 2021

Study Start

January 21, 2020

Primary Completion

January 21, 2023

Study Completion

January 21, 2023

Last Updated

April 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)