MRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions (T2*MRI)

October 23, 2018 updated by: Weill Medical College of Cornell University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
Other: T2* Cardiac and Liver MRI
Patients will undergo an MRI of the heart and liver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
A single T2* MRI will be performed on eligible patients.

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate left ventricular ejection fraction as assessed by T2* MRI.
Time Frame: A single T2* MRI will be performed on eligible patients.
A single T2* MRI will be performed on eligible patients.
Evaluate liver iron concentration as assessed by R2* MRI
Time Frame: A single T2* MRI will be performed on eligible patients.
A single T2* MRI will be performed on eligible patients.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Eric Feldman, M.D., Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 31, 2008

Primary Completion (ACTUAL)

March 29, 2013

Study Completion (ACTUAL)

March 29, 2013

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (ESTIMATE)

September 9, 2008

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0803009687
  • CICL670A US23T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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