IORT-Breast at Medical Center Navicent Health (IORT-Breast)

Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer Female; Early-stage Breast Cancer
• Intervention / Treatment: Procedure: Lumpectomy; Radiation: Intraoperative Radiation Therapy

Detailed Description

Objectives: (primary and important secondary objectives) The primary objective is to determine rates of recurrence at 5, and 10 years following IORT-Breast at Navicent Health.

Secondary objectives include determination of acute and late effects of IORT-Breast at the treatment site, cosmetic outcomes and satisfaction over 10 years.

In addition, the study will determine why patients who were scheduled for IORT-Breast did not receive it after lumpectomy.

Study Design:

Prospective, observational registry.

Setting/Participants:

The study focuses on outpatients/short stay surgery performed at the Medical Center, Navicent Health, Macon, GA only.

Participants have been deemed eligible for IORT-Breast or have received IORT-Breast within the last 6 months. Key eligibility criteria for IORT- Breast includes women, aged 55 years old or greater, diagnosed with clinically node negative, grade 1 or 2 Invasive Breast Cancer with no lymphovascular invasion, that is 20mm or less in greatest dimension, Estrogen Receptor (ER) positive, HER 2 Neu Negative, and with a depth greater than 10mm from skin.

Study Interventions and Measures:

Participants will be eligible for IORT-Breast or have received IORT-Breast in the previous 6 months. Participants who were scheduled for IORT-Breast and do not receive IORT-Breast will have reasons for not receiving IORT-Breast recorded and will not be followed further. Participants receiving IORT-Breast will have treatment parameters recorded and will be followed every 6 months for 2 years and then annually until up to 10 years following treatment.

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Macon, Georgia, United States, 31201
      • Medical Center, Navicent Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated at Navicent Health who meet eligibility criteria for IORT-Breast or who have received IORT-Breast within the previous 6 months

Description

Inclusion Criteria:

• Signed informed consent and HIPAA authorization
• T1 tumor (less than or equal to 20mm in greatest diameter)
• Unifocal
• Histological Grade 1 or 2
• Node Negative
• ER +ve
• HER-2 -ve

Exclusion Criteria:

• Previous radiation therapy to the involved breast other than IORT within 6 months
• High grade tumors (Histologic grade 3)
• Her-2 Positive
• Lymphovascular invasion
• Metastatic disease
• close proximity to or involvement of skin
• Multifocal cancer

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A- Preoperative Prospective; Subjects are eligible to receive IORT and have agreed to participate in the study prior to any intervention.	Procedure: Lumpectomy; Removal of lump/tumor from breast utilizing an approach that saves as much breast as possible.; Other Names: Breast Conserving Surgery; 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; Other Names: IORT
Cohort B- Postoperative Prospective; Subjects who have had IORT performed within the previous 6 month who agree to participate.	Procedure: Lumpectomy; Removal of lump/tumor from breast utilizing an approach that saves as much breast as possible.; Other Names: Breast Conserving Surgery; 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; Other Names: IORT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrence	To determine rate of recurrence of disease at specific time period	5 year
Rate of recurrence	To determine rate of recurrence of disease at specific time period	10 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute and late effects	To determine the rate of acute and late effects of IORT at the treatment site. Periodic review by surgeon and self reports identifying acute and late effects and calculating the rate of incidence for the treated group.	5 years
Treatment Abandonment	To determine rate and reason for abandoning procedure after being scheduled for procedure. Calculating the rate of those who were scheduled to receive IORT and then did not receive the treatment as planned and reason why they did not receive the treatment.	5 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Atrium Health Navicent
• Investigators: Principal Investigator: David Cole, MD, Central Georgia Radiation Oncology; Principal Investigator: Paul Dale, MD, Atrium Health Navicent Physician's Group

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Intraoperative Radiation Therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Surgical Procedures, Operative; Mastectomy; Mastectomy, Segmental
• Other Study ID Numbers: IRB00092014; IORT (Other Identifier: Atrium Health Navicent); H1901940 (Other Identifier: Medical Center Central Georgia IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes