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

NCT02199366 | Completed

• 3 other identifiers: UFPTI 1419-BR02IRB201800163UFJ 2014-116
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Cardiac MRI; Radiation; Proton Radiation; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with changes in cardiac function.

  A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.

  1 year after completion of radiation therapy

Secondary Outcomes (2)

• Proportion of patients with serious cardiac side effects.

  1 year after completion of radiation therapy

• Mean quality of life score.

  1 year after radiation treatment

Study Arms (1)

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)

Interventions

Cardiac magnetic resonance (cardiac MRI) PROCEDURE

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

Also known as: Cardiac MRI, CMR

Cardiac magnetic resonance (cardiac MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Radiation oncology clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Ocala Royal Dames: collaborator

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Julie A Bradley, MD

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 24, 2014
• Study Start: September 1, 2014
• Primary Completion: July 7, 2021
• Study Completion: March 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)