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The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity

This study has been completed.
Sponsor:
Collaborator:
Mallinckrodt
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00530101
First received: September 14, 2007
Last updated: June 3, 2008
Last verified: June 2008
History of Changes
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity

Resource links provided by NLM:

U.S. FDA Resources

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:
    Drug: Doxorubicin

    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

    Other Name: 1177-04-806
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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

No publications provided

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013