IORT-Breast at Medical Center Navicent Health

NCT ID: NCT04595435

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2033-12-31

Brief 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

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.

Conditions

Breast Cancer Female; Early-stage Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A- Preoperative Prospective

Subjects are eligible to receive IORT and have agreed to participate in the study prior to any intervention.

Lumpectomy

Intervention Type: PROCEDURE

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

Intraoperative Radiation Therapy

Intervention Type: RADIATION

Delivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure

Cohort B- Postoperative Prospective

Subjects who have had IORT performed within the previous 6 month who agree to participate.

Lumpectomy

Intervention Type: PROCEDURE

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

Intraoperative Radiation Therapy

Intervention Type: RADIATION

Delivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure

Interventions

Lumpectomy

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

Intervention Type: PROCEDURE

Intraoperative Radiation Therapy

Delivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure

Intervention Type: RADIATION

Other Intervention Names

Breast Conserving Surgery; IORT

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Atrium Health Navicent

UNKNOWN

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Dale, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Navicent Physician's Group

David Cole, MD

Role: PRINCIPAL_INVESTIGATOR

Central Georgia Radiation Oncology

Locations

Medical Center, Navicent Health

Macon, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

H1901940

Identifier Type: OTHER

Identifier Source: secondary_id

IORT

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00092014

Identifier Type: -

Identifier Source: org_study_id