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

NCT ID: NCT00749372

Last Updated: 2018-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-03-29

Brief Summary

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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).

Detailed Description

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Conditions

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Myelodysplastic Syndrome (MDS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type OTHER

T2* Cardiac and Liver MRI

Intervention Type OTHER

Patients will undergo an MRI of the heart and liver.

Interventions

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T2* Cardiac and Liver MRI

Patients will undergo an MRI of the heart and liver.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Feldman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Medical College of Cornell University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CICL670A US23T

Identifier Type: -

Identifier Source: secondary_id

0803009687

Identifier Type: -

Identifier Source: org_study_id

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