MRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions
T2*MRI
T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome
2 other identifiers
interventional
15
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2008
CompletedFirst Submitted
Initial submission to the registry
September 8, 2008
CompletedFirst Posted
Study publicly available on registry
September 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2013
CompletedOctober 25, 2018
October 1, 2018
4.7 years
September 8, 2008
October 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI.
A single T2* MRI will be performed on eligible patients.
Secondary Outcomes (2)
Evaluate left ventricular ejection fraction as assessed by T2* MRI.
A single T2* MRI will be performed on eligible patients.
Evaluate liver iron concentration as assessed by R2* MRI
A single T2* MRI will be performed on eligible patients.
Study Arms (1)
1
OTHERPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Medical College of Cornell University
New York, New York, 10065, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Feldman, M.D.
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2008
First Posted
September 9, 2008
Study Start
July 31, 2008
Primary Completion
March 29, 2013
Study Completion
March 29, 2013
Last Updated
October 25, 2018
Record last verified: 2018-10