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

Study Overview
=================
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.

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

Conditions
-----------------
Iron Overload

Intervention / Treatment
-----------------
* Diagnostic Test: Npf.


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Npf.|3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 | 
| 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

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron, T2* mapping, MRI relaxometry, transfusion