Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedStudy Start
First participant enrolled
September 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2024
CompletedOctober 1, 2024
July 1, 2023
5.8 years
November 16, 2015
September 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiotoxicity
Cardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment
1 year after completion of treatment
Study Arms (1)
CMR/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
Interventions
Subjects will be recruited for observational cardiac magnetic resonance imaging.
Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.
Eligibility Criteria
Breast Cancer
You may qualify if:
- 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.
You may not qualify if:
- Contraindication to contrast CMR including eGFR \<30 mls/min/1.73m2
- Uncontrolled serious concurrent illness
- Pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- American Heart Associationcollaborator
- Dana-Farber Cancer Institutecollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reza Nezafat, Ph.D
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 16, 2015
First Posted
January 28, 2016
Study Start
September 10, 2018
Primary Completion
July 10, 2024
Study Completion
July 10, 2024
Last Updated
October 1, 2024
Record last verified: 2023-07