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

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00749372
• Collaborator: Novartis Pharmaceuticals (Industry)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 55.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome (MDS)	Other: T2* Cardiac and Liver MRI	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome
• Actual Study Start Date: Jul 31, 2008
• Actual Primary Completion Date: Mar 29, 2013
• Actual Study Completion Date: Mar 29, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Evaluate left ventricular ejection fraction as assessed by T2* MRI. [A single T2* MRI will be performed on eligible patients.]

2. Evaluate liver iron concentration as assessed by R2* MRI [A single T2* MRI will be performed on eligible patients.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Weill Medical College of Cornell University	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University
• Novartis Pharmaceuticals

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT00749372
• Other Study ID Numbers: 0803009687; CICL670A US23T
• First Posted: Sep 9, 2008
• Last Update Posted: Oct 25, 2018
• Last Verified: Oct 1, 2018

• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome

Study Results

No Results Posted as of Oct 25, 2018