Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02666378|
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Cardiac Magnetic Resonance Imaging (CMR) Other: Echocardiogram (ECHO)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer|
|Actual Study Start Date :||September 10, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||July 2021|
Prior to starting chemotherapy treatment, the participant will undergo the following procedures:
Other: Cardiac Magnetic Resonance Imaging (CMR)
Subjects will be recruited for observational cardiac magnetic resonance imaging.
Other Name: MRI
Other: Echocardiogram (ECHO)
Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.
- Cardiotoxicity [ Time Frame: 1 year after completion of treatment ]Cardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666378
|Contact: Reza Nezafat, Ph.D||617-667-1747||Rnezafat@bidmc.harvard.edu|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Reza Nezafat, Ph.D 617-667-1747 Rnezafat@bidmc.harvard.edu|
|Principal Investigator: Reza Nezafat, Ph.D|
|Principal Investigator:||Reza Nezafat, Ph.D||Beth Israel Deaconess Medical Center|