The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity - Full Text View

Sponsors and Collaborators:	University of Miami Mallinckrodt
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00530101

Purpose

The purpose of this research study is to evaluate MR imaging in subjects receiving doxorubicin chemotherapy to see if MR can detect heart damage as well as or better than MUGA scans.

This research study is expected to enroll approximately 10 subjects over 12 months at the University of Miami / Miller School of Medicine.

Condition	Intervention	Phase
Breast Cancer	Drug: Doxorubicin	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans

Drug Information available for: Doxorubicin Doxorubicin hydrochloride BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity

Further study details as provided by University of Miami:

Primary Outcome Measures:

The purpose of this research study is to evaluate MR imaging in subjects receiving doxorubicin chemotherapy to see if MR can detect heart damage as well as or better than MUGA scans. [ Time Frame: Over a period of 12 months ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	July 2004
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

This pilot study will select patients who are at increased likelihood to develop cardiotoxicity, due to borderline cardiac function at baseline, advanced age, or the anticipation of a high cumulative dose of administered doxorubicin. Patients who will receive radiation therapy to the left chest during chemotherapy (i.e., left breast cancer) will be excluded so as to eliminate possible cardiotoxic effects from radiation. CMR studies will be performed at no charge to the patient, supported by the sponsor of this study. CMR imaging will be subject to IRB approval, informed consent, and HIPAA regulations. Contrast-enhanced CMR will be obtained at three time points:

Patients will not undergo contrast-enhanced MR unless calculated GFR is equal to or greater than 60 mL/min/1.73 m2

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Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must have breast cancer and undergoing radiation treatment with a likelihood of developing cardiotoxicity.

Exclusion Criteria:

Healthy subjects
Males
Subjects under the age of 18

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530101

Locations

United States, Florida
University of Miami Dept of Radiology
Miami, Florida, United States, 33136
University of Miami Dept of Hematology/Oncology
Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Mallinckrodt

Investigators

Principal Investigator:

Joel Fishman, MD

University of Miami

More Information

Responsible Party:	University of Miami ( Dr. Joel Fishman )
Study ID Numbers:	1177-04-806, 20043031 and 20050866
Study First Received:	September 14, 2007
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00530101
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009