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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
342
Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.
Virginia Commonwealth University
Richmond, Virginia, United States
Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.
Time frame: 5 years
Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.
Time frame: 5 years
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