Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy

NCT ID: NCT02199366

Last Updated: 2025-06-11

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

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2025-03-31

Brief Summary

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This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.

Detailed Description

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As part of this study, participants will have a cardiac MRI at baseline and a follow-up cardiac MRI within 1 year after completion of standard radiation therapy for left-sided breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in cardiac function within 1 year after radiation treatment.

Patients will be asked to complete a questionnaire before and after treatment that asks about their health and any symptoms they may be having.

Physical exams and any other standard of care service or treatment will be at the discretion of the treating physician.

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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Cardiac magnetic resonance (cardiac MRI)

Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.

Cardiac magnetic resonance (cardiac MRI)

Intervention Type PROCEDURE

Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.

Interventions

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Cardiac magnetic resonance (cardiac MRI)

Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.

Intervention Type PROCEDURE

Other Intervention Names

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Cardiac MRI CMR

Eligibility Criteria

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Inclusion Criteria

* Left-sided breast cancer stage I-III.
* Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT).
* Women and men are allowed.
* Must be at least 18 years old at time of consent.

Exclusion Criteria

* Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study.
* Prior history of cardiovascular disease per physician discretion.
* Stage 0 and IV breast cancer.
* Prior radiation therapy to chest.
* Concurrent trastuzumab per physician discretion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocala Royal Dames

UNKNOWN

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie A Bradley, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida Proton Therapy Institute

Locations

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University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201800163

Identifier Type: OTHER

Identifier Source: secondary_id

UFJ 2014-116

Identifier Type: OTHER

Identifier Source: secondary_id

UFPTI 1419-BR02

Identifier Type: -

Identifier Source: org_study_id

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