Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy
This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.
|Study Design:||Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use|
- Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||June 2013|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Conture Multi-Lumen Balloon
Device: Conture Multi-Lumen Balloon
Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.
Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298-0058|
|Study Chair:||Douglas W. Arthur, MD||Virginia Commonwealth University|