MRI T2* Mapping of Myocardium, Liver, Pancreas and Pituitary Gland

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology (Other)

Overall Status

Recruiting

CT.gov ID

NCT04835285

Collaborator

(none)

152

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Overload	Diagnostic Test: Npf.	N/A

Detailed Description

All patients were investigated using a 3T MRI scanner (Philips Achieva) and 1,5 T MRI scanner (GE Signa) with 8-channel surface coil for body scanning. For myocardium, pancreas and pituitary gland iron overload quantification in children we have used special sequences for T2-mapping based on fast gradient echo sequences - multi-phase fast gradient echo and ultrashort gradient echo (uTE) in axial and coronary plane. For breath-hold acquisition due to failure of communication and invariable behavior some children received anaesthetic support with mechanical ventilation. Miocardium, pancreas and pituitary gland T2 relaxometry maps were calculated automatically by commertial application ReportCARD Functool (GE Healthcare) and integrated Philips T2* maps.

The placement of region of interest (ROI) in target organ were performed by following criterion: for the myocardium - in the interventricular septum in short axis plane; for the pancreas - in corpus in axial plane; for the pituitary gland - in adenohypophysis; for all organs the area of large and small blood vessels, which can introduce distortions of the obtained results were excluded. Then for selected ROI T2* data acquisition in milisecond [ms] were performed and calculated automatically by approximating the attenuation curve with the highest likelihood method.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

152 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Clinical Study of MRI Assessment of Iron in the Myocardium, Liver, Pancreas and Pituitary Gland in Patients With High Transfusion Dependence on the Packed Red Blood Cells

Actual Study Start Date :

Jan 21, 2020

Anticipated Primary Completion Date :

Jan 21, 2023

Anticipated Study Completion Date :

Jan 21, 2023

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Age under 25 y.o.;
A history of transfusion-dependent anemia of various origins.
indications for the appointment of chelation therapy

Non-inclusion criteria:

Age over 25 y.o.
The number of RBC transfusions previously received by the patient is less than 10

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology	Moscow	Samory-Mashela,1	Russian Federation	11198

Sponsors and Collaborators

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Investigators

Study Director: Galina f Tereshchenko, PhD, Chief radiology department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

ClinicalTrials.gov Identifier:

NCT04835285

Other Study ID Numbers:

NCPHOI-2019-09

First Posted:

Apr 8, 2021

Last Update Posted:

Apr 8, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Additional relevant MeSH terms:

Iron Overload

Study Results

No Results Posted as of Apr 8, 2021