Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02666378
• Other study ID #: 15-017
• Status: Recruiting
• Start date: September 10, 2018
• Est. completion date: July 10, 2024

Study information

• Verified date: July 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Reza Nezafat, Ph.D
• Phone: 617-667-1747
• Email: Rnezafat[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: July 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity

Intervention

Other:
• Cardiac Magnetic Resonance Imaging (CMR)
Subjects will be recruited for observational cardiac magnetic resonance imaging.
• Echocardiogram (ECHO)
Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	American Heart Association, Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiotoxicity	Cardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment	1 year after completion of treatment