Back to resultsMRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions (T2*MRI)
Primary Purpose
Myelodysplastic Syndrome (MDS)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T2* Cardiac and Liver MRI
Sponsored by
About this trial
This is an interventional screening trial for Myelodysplastic Syndrome (MDS)
Eligibility Criteria
Inclusion Criteria:
- Male or Female patients will need documentation of diagnosis of Myelodysplastic Syndrome by previous bone marrow exam
- Male or female patients with MDS who have received at least 50 units of Red Blood Cell Transfusions.
- Serum ferritin > 1,000
- Written informed consent by the patient.
Exclusion Criteria:
- Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia.
Sites / Locations
- Weill Medical College of Cornell University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Patients who meet eligibility will be sent for radiographic imaging to include T2* cardiac and liver MRI to ascertain quantification of organ-specific iron concentrations as well as cardiac left ventricular ejection fraction.
Outcomes
Primary Outcome Measures
To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI.
Secondary Outcome Measures
Evaluate left ventricular ejection fraction as assessed by T2* MRI.
Evaluate liver iron concentration as assessed by R2* MRI
Full Information
NCT ID
NCT00749372
First Posted
September 8, 2008
Last Updated
October 23, 2018
Sponsor
Weill Medical College of Cornell University
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00749372
Brief Title
MRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions
Acronym
T2*MRI
Official Title
T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 31, 2008 (Actual)
Primary Completion Date
March 29, 2013 (Actual)
Study Completion Date
March 29, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
A known risk of red blood cell transfusions is that it puts excess iron into the patient's body. Researchers are continually seeking the most effective method of measuring iron concentration. The purpose of this study is to determine how much iron has been deposited in a patient's heart and liver as a result of having received red blood cell transfusions using magnetic resonance imaging (MRI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome (MDS)
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Patients who meet eligibility will be sent for radiographic imaging to include T2* cardiac and liver MRI to ascertain quantification of organ-specific iron concentrations as well as cardiac left ventricular ejection fraction.
Intervention Type
Other
Intervention Name(s)
T2* Cardiac and Liver MRI
Intervention Description
Patients will undergo an MRI of the heart and liver.
Primary Outcome Measure Information:
Title
To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI.
Time Frame
A single T2* MRI will be performed on eligible patients.
Secondary Outcome Measure Information:
Title
Evaluate left ventricular ejection fraction as assessed by T2* MRI.
Time Frame
A single T2* MRI will be performed on eligible patients.
Title
Evaluate liver iron concentration as assessed by R2* MRI
Time Frame
A single T2* MRI will be performed on eligible patients.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female patients will need documentation of diagnosis of Myelodysplastic Syndrome by previous bone marrow exam
Male or female patients with MDS who have received at least 50 units of Red Blood Cell Transfusions.
Serum ferritin > 1,000
Written informed consent by the patient.
Exclusion Criteria:
Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Feldman, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions
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