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

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: NCT02199366
Recruitment Status : Recruiting
First Posted : July 24, 2014
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Ocala Royal Dames
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Cardiac magnetic resonance (cardiac MRI)

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 26 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 : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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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.
 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:
  • Cardiac MRI
  • CMR


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Radiation oncology clinic
Criteria

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.
Contacts and Locations
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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): NCT02199366


Contacts
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Contact: Intake Coordinator 877-686-6009

Locations
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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         
Sponsors and Collaborators
University of Florida
Ocala Royal Dames
Investigators
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Principal Investigator: Julie A Bradley, MD University of Florida Proton Therapy Institute
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02199366    
Other Study ID Numbers: UFPTI 1419-BR02
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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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:
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Breast Neoplasms
Unilateral Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases