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Completed

NCT Number: NCT00749372

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

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).

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Key information

Conditions

Myelodysplastic Syndrome (MDS) Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Medical College of Cornell University

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T2* Cardiac and Liver MRI

Other

Patients will undergo an MRI of the heart and liver.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evaluate left ventricular ejection fraction as assessed by T2* MRI.

    Time frame: A single T2* MRI will be performed on eligible patients.

  2. Evaluate liver iron concentration as assessed by R2* MRI

    Time frame: A single T2* MRI will be performed on eligible patients.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

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

Acronym: T2*MRI

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 9, 2008
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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