Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

NCT ID: NCT02666378

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-10

Study Completion Date

2024-07-10

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Cardiac Magnetic Resonance Imaging (CMR)

Intervention Type OTHER

Subjects will be recruited for observational cardiac magnetic resonance imaging.

Echocardiogram (ECHO)

Intervention Type OTHER

Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.

Interventions

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Cardiac Magnetic Resonance Imaging (CMR)

Subjects will be recruited for observational cardiac magnetic resonance imaging.

Intervention Type OTHER

Echocardiogram (ECHO)

Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.

Intervention Type OTHER

Other Intervention Names

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MRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Reza Nezafat

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reza Nezafat, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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15-017

Identifier Type: -

Identifier Source: org_study_id

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