IORT-Breast at Medical Center Navicent Health

NCT04595435 | Active Not Recruiting FDA Device

• 3 other identifiers: IRB00092014H1901940IORT
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer Female; Early-stage Breast Cancer

Keywords

Intraoperative Radiation Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Acute and late effects

  5 years

• Treatment Abandonment

  5 years

Study Arms (2)

Cohort A- Preoperative Prospective

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

Procedure: Lumpectomy; Radiation: Intraoperative Radiation Therapy

Cohort B- Postoperative Prospective

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

Procedure: Lumpectomy; Radiation: Intraoperative Radiation Therapy

Interventions

Lumpectomy PROCEDURE

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

Also known as: Breast Conserving Surgery

Cohort A- Preoperative Prospective; Cohort B- Postoperative Prospective

Intraoperative Radiation Therapy RADIATION

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

Also known as: IORT

Cohort A- Preoperative Prospective; Cohort B- Postoperative Prospective

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Navicent: collaborator

Study Sites (1)

Medical Center, Navicent Health

Macon, Georgia, 31201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Paul Dale, MD

  Atrium Health Navicent Physician's Group

  PRINCIPAL INVESTIGATOR

• David Cole, MD

  Central Georgia Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: October 20, 2020
• Study Start: March 19, 2019
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)