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The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity

NCT00530101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2008-06-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Joel Fishman, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00530101 on ClinicalTrials.gov