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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04835285
Enrollment
152
Registered
2021-04-08
Start date
2020-01-21
Completion date
2023-01-21
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Overload

Keywords

Iron, T2* mapping, MRI relaxometry, transfusion

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.

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.

Interventions

DIAGNOSTIC_TESTNpf.

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

Sponsors

Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
No

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 Non-inclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Russia

Contacts

Primary ContactEvelina f Nazarova
evelina.nazarova@fccho-moscow.ru+79161133945

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026