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Brief Title: A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
Official Title: A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
Study ID: NCT01478438
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
The Breast Center of Southern Arizona, Tucson, Arizona, United States
Rose Medical Center - Rose Breast Center, Denver, Colorado, United States
St. Alexius Breast Care of St. Alexius Medical Center, Bartlett, Illinois, United States
Advocate Lutheran General Hospital - Caldwell Breast Center, Park Ridge, Illinois, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Columbia University Medical Center - Department of Surgery, New York, New York, United States
University of Toledo - Eleanor N. Dana Cancer Center Breast Care, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Wheaton Franciscan Health System, Wauwatosa, Wisconsin, United States
North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre, Bristol, , United Kingdom
Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit, Chelmsford, , United Kingdom
Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital, Norwich, , United Kingdom
Name: Barbara Schwartzberg, MD
Affiliation: Rose Medical Center - Rose Breast Center
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Shere, M.D.
Affiliation: North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
Role: PRINCIPAL_INVESTIGATOR