A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
This study will determine the rate of complete tumor ablation of small breast cancers (≤ 20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post ILT ablation as correlated to histopathology from the post-ablation excision.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers|
- Collect information on the proportion of tumors ablated for sample size calculations in the pivotal trial [ Time Frame: one month end point ] [ Designated as safety issue: No ]
Evaluate the rate of complete tumor ablation by Novilase ILT of small breast cancers and characterize the correlation of imaging (MR, US, x-ray) in detecting residual post ablation with histopathology of the excised specimen.
An individual patient will be considered to have a complete ablation if the pathology results post excision demonstrates that no visible gross residual tumor is present.
- To gain experience with the cosmetic outcome and rate of recovery tools [ Time Frame: One month end point ] [ Designated as safety issue: No ]Evaluate satisfaction, utilizing the European Organization for Research and Treatment of Cancer Breast Cancer Specific Quality of Life Questionnaire (EORTC QLQ-BR23) survey and cosmetic outcome utilizing the physician-reported Four-Point Scoring System of Breast Cosmesis.
|Study Start Date:||April 2012|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Treat and Excise
All subjects will be treated with Interstitial Laser Therapy (ILT) followed by excision no later than 28 days post ablation.
Device: Novilase Interstitial Laser Therapy
Image guided Interstitial Laser Ablation of breast tumors
Other Name: Novilase®
|Contact: Eugene Bajorinas||312-266-7200 ext firstname.lastname@example.org|
|Contact: Marti DeLay||312-266-7200 ext email@example.com|
|United States, Colorado|
|Rose Breast Center||Recruiting|
|Denver, Colorado, United States, 80220|
|Contact: Ingrid Van Den Abbeele 303-320-7138 firstname.lastname@example.org|
|Principal Investigator: Barbara Schwartzberg, M.D.|
|United States, Illinois|
|St. Alexius Breast Care of St. Alexius Medical Center||Recruiting|
|Bartlett, Illinois, United States, 60103|
|Contact: Karen Bland 847-755-8700 email@example.com|
|Principal Investigator: Robert Maganini, M.D.|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73126|
|Contact: Alicia Hancock 405-271-4514 firstname.lastname@example.org|
|Contact: Ronald Squires, M.D. 405-271-4514 email@example.com|
|Principal Investigator: William Dooley, M.D.|
|Principal Investigator:||Barbara Schwartzberg, MD||Rose Breast Center|
|Principal Investigator:||William C Dooley, MD||University of Oklahoma|
|Principal Investigator:||Robert O Maganini, MD||Alexian Brothers Health System|