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

NCT ID: NCT04835285

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2023-01-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Iron Overload

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Npf.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

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

6 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal Research Institute of Pediatric Hematology, Oncology and Immunology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Galina f Tereshchenko, PhD

Role: STUDY_DIRECTOR

Chief radiology department

Locations

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

Moscow, Samory-Mashela,1, Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Evelina f Nazarova

Role: CONTACT

+79161133945

Facility Contacts

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Evelina f Nazarova

Role: primary

+79161133945

Other Identifiers

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NCPHOI-2019-09

Identifier Type: -

Identifier Source: org_study_id

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