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ACTIVE NOT RECRUITING
NCT02400658
NA

Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer

Sponsor: Shayna Showalter, MD

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.

Official title: A Prospective 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

Key Details

Gender

FEMALE

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2015-03

Completion Date

2027-09

Last Updated

2023-01-25

Healthy Volunteers

No

Conditions

Interventions

DEVICE

IORT with CT-Guided HDR Brachytherapy

This therapy targets the cancer cells directly, reducing the volume of breast tissue exposed to the radiation and the risks involved with the radiation. CT imaging will be used via a multichannel/multi-dwell balloon catheter to better sculpt the cancer away from the heart, skin, and ribs.

Locations (3)

Hackensack Meridian Health - John Theurer Cancer Center

Hackensack, New Jersey, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States