MRI T2* Mapping of Myocardium, Liver, Pancreas and Pituitary Gland
Primary Purpose
Iron Overload
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Npf.
Sponsored by
About this trial
This is an interventional diagnostic trial for Iron Overload focused on measuring Iron, T2* mapping, MRI relaxometry, transfusion
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.
Sites / Locations
- Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and ImmunologyRecruiting
Outcomes
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.
Compare and contrast T2* values in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia using 1.5T and 3T MRI scanner.
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.
To develop a control method for iron assessment using aqueous solutions of iron nanoparticles by calculating T2* values on 3T and 1,5T scanners.
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.
Full Information
NCT ID
NCT04835285
First Posted
March 29, 2021
Last Updated
April 5, 2021
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
1. Study Identification
Unique Protocol Identification Number
NCT04835285
Brief Title
MRI T2* Mapping of Myocardium, Liver, Pancreas and Pituitary Gland
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
January 21, 2023 (Anticipated)
Study Completion Date
January 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Overload
Keywords
Iron, T2* mapping, MRI relaxometry, transfusion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Npf.
Intervention Description
3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload
Primary Outcome Measure Information:
Title
Compare and contrast T2* values in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia using 1.5T and 3T MRI scanner.
Time Frame
Initially, after one month of chelation therapy
Title
Compare and contrast T2* values in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia using 1.5T and 3T MRI scanner.
Time Frame
up to 1 week after the end of chelation therapy
Secondary Outcome Measure Information:
Title
To calculate the T2* values in the pancreas, myocardium and pituitary gland in patients with transfusion-dependent anemia on the 3T scanner.
Time Frame
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
Title
To develop a control method for iron assessment using aqueous solutions of iron nanoparticles by calculating T2* values on 3T and 1,5T scanners.
Time Frame
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
Title
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.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evelina f Nazarova
Phone
+79161133945
Email
evelina.nazarova@fccho-moscow.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galina f Tereshchenko, PhD
Organizational Affiliation
Chief radiology department
Official's Role
Study Director
Facility Information:
Facility Name
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
City
Moscow
State/Province
Samory-Mashela,1
ZIP/Postal Code
11198
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelina f Nazarova
Phone
+79161133945
Email
evelina.nazarova@fccho-moscow.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MRI T2* Mapping of Myocardium, Liver, Pancreas and Pituitary Gland
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