Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

Beth Israel Lahey Health

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Echocardiogram (ECHO); Other: Cardiac Magnetic Resonance Imaging (CMR)

Study type: Observational

Funder types: Other

Identifiers

NCT02666378

15-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

CMR/ECHO

Description:

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

Treatment:

Other: Cardiac Magnetic Resonance Imaging (CMR)

Other: Echocardiogram (ECHO)