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

Iron Overload Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835285
• Other study ID #: NCPHOI-2019-09
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: January 21, 2023

Study information

• Verified date: March 2021
• Source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Contact: Evelina f Nazarova
• Phone: +79161133945
• Email: evelina.nazarova[@]fccho-moscow.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: January 21, 2023
• Est. primary completion date: January 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Iron Overload

Intervention

Diagnostic Test:
• Npf.
3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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