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Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02666378
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Reza Nezafat, PhD, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Cardiac Magnetic Resonance Imaging (CMR) Other: Echocardiogram (ECHO) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Reza Nezafat, Ph.D 617-667-1747 Rnezafat@bidmc.harvard.edu

Locations
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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         
Sponsors and Collaborators
Dana-Farber Cancer Institute
American Heart Association
Investigators
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Principal Investigator: Reza Nezafat, Ph.D Beth Israel Deaconess Medical Center

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Responsible Party: Reza Nezafat, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02666378    
Other Study ID Numbers: 15-017
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries