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IORT-Breast at Medical Center Navicent Health

NCT04595435 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2026-01-29

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

  • Atrium Health Navicent

    collaborator UNKNOWN

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Paul Dale, MD · Atrium Health Navicent Physician's Group

  • David Cole, MD · Central Georgia Radiation Oncology

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2033-12-31
Completion
2033-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04595435 on ClinicalTrials.gov