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Sponsors and Collaborators: |
University of Miami Mallinckrodt |
---|---|
Information provided by: | University of Miami |
ClinicalTrials.gov Identifier: | NCT00530101 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity |
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) |
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
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Joel Fishman, MD | University of Miami |
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 |
Skin Diseases Breast Neoplasms Doxorubicin Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |