NCT01988870

IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer

A Pilot, Single Arm, Study of the Safety and Feasibility of Single-Fraction Intraoperative Radiation Treatment (IORT) With CT-On-Rails-Guided HDR Brachytherapy for the Treatment of Early-Stage Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Shayna Showalter, MD · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery. Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Intra-operative Radiation Therapy (IORT)	IORT is a form of APBI (accelerated partial breast irradiation) that allows for a high degree of dose homogeneity, exclusion of non-affected structures, and reduction of the volume of breast tissue exposed.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-04-01
• Completion: 2015-11-01
• First posted: 2013-11-20
• Last updated: 2016-11-22

Locations

1 site across 1 country: United States