Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Locations
United States
Study Type
Observational
Intervention
Cardiac Magnetic Resonance Imaging (CMR)
Echocardiogram (ECHO)
Sponsored by
About this trial
This is an observational trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Arm Label
CMR/ECHO
Arm 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
Outcomes
Primary Outcome Measures
Cardiotoxicity
Cardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT02666378
First Posted
November 16, 2015
Last Updated
July 7, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
American Heart Association, Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02666378
Brief Title
Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
Official Title
Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
Study Type
Observational
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
July 10, 2024 (Anticipated)
Study Completion Date
July 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
American Heart Association, Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CMR/ECHO
Arm 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
Intervention Type
Other
Intervention Name(s)
Cardiac Magnetic Resonance Imaging (CMR)
Other Intervention Name(s)
MRI
Intervention Description
Subjects will be recruited for observational cardiac magnetic resonance imaging.
Intervention Type
Other
Intervention Name(s)
Echocardiogram (ECHO)
Intervention Description
Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.
Primary Outcome Measure Information:
Title
Cardiotoxicity
Description
Cardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment
Time Frame
1 year after completion of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
Breast Cancer
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reza Nezafat, Ph.D
Phone
617-667-1747
Email
Rnezafat@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Nezafat, Ph.D
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reza Nezafat, Ph.D
Phone
617-667-1747
Email
Rnezafat@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Reza Nezafat, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
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