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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00749372
First received: September 8, 2008
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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).


Condition Intervention
Myelodysplastic Syndrome (MDS)
Other: T2* Cardiac and Liver MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate left ventricular ejection fraction as assessed by T2* MRI. [ Time Frame: A single T2* MRI will be performed on eligible patients. ] [ Designated as safety issue: No ]
  • Evaluate liver iron concentration as assessed by R2* MRI [ Time Frame: A single T2* MRI will be performed on eligible patients. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749372

Contacts
Contact: Tania Curcio, R.N. 212-746-2571

Locations
United States, New York
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Tania Curcio, R.N.    212-746-2571      
Principal Investigator: Eric Feldman, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Novartis Pharmaceuticals
Investigators
Principal Investigator: Eric Feldman, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Eric Feldman, M.D. / Professor of Medicine, Weill Cornell Medicial College
ClinicalTrials.gov Identifier: NCT00749372     History of Changes
Other Study ID Numbers: 0803009687, CICL670A US23T
Study First Received: September 8, 2008
Last Updated: November 4, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014