The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity
2 other identifiers
interventional
3
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 breast-cancer
Started Jul 2004
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 14, 2007
CompletedFirst Posted
Study publicly available on registry
September 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJune 4, 2008
June 1, 2008
3.7 years
September 14, 2007
June 3, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Over a period of 12 months
Interventions
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
Eligibility Criteria
You may qualify if:
- Subject must have breast cancer and undergoing radiation treatment with a likelihood of developing cardiotoxicity.
You may not qualify if:
- Healthy subjects
- Males
- Subjects under the age of 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Mallinckrodtcollaborator
Study Sites (2)
University of Miami Dept of Hematology/Oncology
Miami, Florida, 33136, United States
University of Miami Dept of Radiology
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Fishman, MD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2007
First Posted
September 17, 2007
Study Start
July 1, 2004
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
June 4, 2008
Record last verified: 2008-06