Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy
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ClinicalTrials.gov Identifier: NCT02199366 |
Recruitment Status
:
Recruiting
First Posted
: July 24, 2014
Last Update Posted
: March 8, 2018
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Condition or disease | Intervention/treatment |
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Breast Cancer | Procedure: Cardiac magnetic resonance (cardiac MRI) |
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.
Study Type : | Observational |
Estimated Enrollment : | 16 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy |
Study Start Date : | September 2014 |
Estimated Primary Completion Date : | November 2018 |
Estimated Study Completion Date : | July 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Cardiac magnetic resonance (cardiac MRI)
Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.
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Procedure: Cardiac magnetic resonance (cardiac MRI)
Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.
Other Names:
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- Proportion of participants with changes in cardiac function. [ Time Frame: 1 year after completion of radiation therapy ]A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.
- Proportion of patients with serious cardiac side effects. [ Time Frame: 1 year after completion of radiation therapy ]Includes myocardial infarction, valve disorder, congestive heart failure, and angina.
- Mean quality of life score. [ Time Frame: 1 year after radiation treatment ]Comparison of baseline and post treatment quality of life questionnaires completed by participants.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
- Contraindications to cardiac MRI (e.g., contrast reaction, metal implants, etc.).

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): NCT02199366
Contact: Intake Coordinator | 877-686-6009 |
United States, Florida | |
University of Florida Proton Therapy Institute | Recruiting |
Jacksonville, Florida, United States, 32206 | |
Contact: Intake Coordinator 877-686-6009 | |
Principal Investigator: Julie A Bradley, MD |
Principal Investigator: | Julie A Bradley, MD | University of Florida Proton Therapy Institute |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT02199366 History of Changes |
Other Study ID Numbers: |
UFPTI 1419-BR02 |
First Posted: | July 24, 2014 Key Record Dates |
Last Update Posted: | March 8, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University of Florida:
Cardiac MRI Radiation Proton Radiation Breast Cancer |
Additional relevant MeSH terms:
Breast Neoplasms Unilateral Breast Neoplasms Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases |