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Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02666378
Enrollment
50
Registered
2016-01-28
Start date
2018-09-10
Completion date
2024-07-10
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

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.

Sponsors

American Heart Association
CollaboratorOTHER
Dana-Farber Cancer Institute
CollaboratorOTHER
Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiotoxicity1 year after completion of treatmentCardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026