Research study for Early Stage Breast Cancer

IRB/UVA Tracking #
Principal Investigator
Shayna L Showalter
Katie Rea
Contact Email
Contact Phone
Official Trial Title
A Prospective Multi-site Single- Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early -Stage Breast Cancer
Study Description

The University of Virginia, Department of Surgery is seeking women 45 and older with early stage breast cancer for Intraoperative Radiation Therapy Study

The purpose of the study is to determine how effective image-guided intraoperative radiation therapy (IORT) is for the treatment of early stage breast cancers. The IORT system allows physicians to obtain a CT scan image of the breast which is used to plan and deliver the radiation therapy. The study would like to see if IORT is effective when delivered either during surgery to remove the breast cancer or within 30 days of the breast cancer surgery. The study will also look at patient side effects and outcomes after IORT and compare it to those patients who receive traditional radiation therapy treatments. Whole breast radiation is one type of traditional radiation therapy.

The study involves 12 study visits over 5 years; all visits occur during routine cancer treatment visits. No additional visits are required. Participation involves medical history review, physical exam, a serum pregnancy test (if indicated), blood samples, mammogram, and the investigational treatment. Questionnaires and digital photos are also a part of this study.

Study-related labs will be provided free of charge.

Ages: 45 years old and older


No Compensation