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IORT-Breast at Medical Center Navicent Health
Sponsor: Wake Forest University Health Sciences
Summary
Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes. Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance
Official title: Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health
Key Details
Gender
FEMALE
Age Range
55 Years - Any
Study Type
OBSERVATIONAL
Enrollment
94
Start Date
2019-03-19
Completion Date
2033-12-31
Last Updated
2026-01-29
Healthy Volunteers
No
Interventions
Lumpectomy
Removal of lump/tumor from breast utilizing an approach that saves as much breast as possible.
Intraoperative Radiation Therapy
Delivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure
Locations (1)
Medical Center, Navicent Health
Macon, Georgia, United States