Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Other: Cardiac Magnetic Resonance Imaging (CMR); Other: Echocardiogram (ECHO)

• Registration Number: NCT02666378
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Study Start: 2018-09-10
• Status Verified: 2023-07
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-10
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CMR/ECHO	Echocardiogram (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
CMR/ECHO	Cardiac Magnetic Resonance Imaging (CMR)	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

Primary Outcome Measures

Name	Time	Method
Cardiotoxicity	1 year after completion of treatment	Cardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States