MRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions

Myelodysplastic Syndrome (MDS) Clinical Trial

— T2*MRI  

Official title:

T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749372
• Other study ID #: 0803009687
• Secondary ID: CICL670A US23T
• Status: Completed
• Phase: N/A
• Start date: July 31, 2008
• Est. completion date: March 29, 2013

Study information

• Verified date: October 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 29, 2013
• Est. primary completion date: March 29, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Other:
• T2* Cardiac and Liver MRI
Patients will undergo an MRI of the heart and liver.

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate left ventricular ejection fraction as assessed by T2* MRI.		A single T2* MRI will be performed on eligible patients.
Secondary	Evaluate liver iron concentration as assessed by R2* MRI		A single T2* MRI will be performed on eligible patients.