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NCT Number: NCT02666378

Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac magnetic resonance imaging (CMR)

Other

Subjects will be recruited for observational cardiac magnetic resonance imaging.

Other names: MRI

Echocardiogram (ECHO)

Other

Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • American Heart Association
  • Dana-Farber Cancer Institute

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 28, 2016
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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