Myelodysplastic Syndrome (MDS)
Conditions
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).
Interventions
OTHERT2* Cardiac and Liver MRI
Patients will undergo an MRI of the heart and liver.
Sponsors
Novartis Pharmaceuticals
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Outcome results
None listed