Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

September 27, 2024 updated by: Reza Nezafat, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Breast Cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CMR/ECHO

Prior to starting chemotherapy treatment, the participant will undergo the following procedures:

  • Cardiac Magnetic Resonance Imaging (CMR)
  • Echocardiogram (ECHO) in patients with no clinically indicated scans
  • Each imaging procedure will be repeated at predetermined times during the protocol
  • Simple blood collection for plasma biomarker analysis
Other: Cardiac Magnetic Resonance Imaging (CMR)
Subjects will be recruited for observational cardiac magnetic resonance imaging.
Other Names:
  • MRI
Other: Echocardiogram (ECHO)
Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Dana-Farber Cancer Institute
American Heart Association

Investigators

  • Principal Investigator: Reza Nezafat, Ph.D, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

July 10, 2024

Study Completion (Actual)

July 10, 2024

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimated)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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