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ACTIVE NOT RECRUITING
NCT04595435

IORT-Breast at Medical Center Navicent Health

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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

PROCEDURE

Lumpectomy

Removal of lump/tumor from breast utilizing an approach that saves as much breast as possible.

RADIATION

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