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Clinical Trials/NCT02666378
NCT02666378
Completed
Not Applicable

Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

Beth Israel Deaconess Medical Center1 site in 1 country50 target enrollmentSeptember 10, 2018
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
50
Locations
1
Primary Endpoint
Cardiotoxicity
Status
Completed
Last Updated
last year

Overview

Brief Summary

This research study is evaluating the use of Cardiac Magnetic Resonance Imaging (CMR) as a method of detecting early signs of damage to the heart that can be associated with anthracycline-based chemotherapy for the treatment of breast cancer.

Detailed Description

One of the side effects observed in breast cancer patients receiving anthracycline-based treatment is heart complications in which the heart muscle is weakened and no longer able to pump sufficient amounts of blood throughout the body. This complication can lead to the following symptoms: shortness of breath on exertion, swollen ankles and feet, lack of energy and a reduced capacity to carry out day-to-day activities. This research study is focused on identifying the early signs of such heart complications using CMR, which may allow preventative treatment options to be made available in future.

Registry
clinicaltrials.gov
Start Date
September 10, 2018
End Date
July 10, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reza Nezafat

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years
  • Have histologic diagnosis of breast carcinoma
  • Scheduled to receive standard clinical therapy designed by their treating oncologist
  • Patients should receive anthracycline as part of the recommended treatment
  • Able to give informed consent.

Exclusion Criteria

  • Contraindication to contrast CMR including eGFR \<30 mls/min/1.73m2
  • Uncontrolled serious concurrent illness
  • Pregnancy or breast feeding

Outcomes

Primary Outcomes

Cardiotoxicity

Time Frame: 1 year after completion of treatment

Cardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment

Study Sites (1)

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