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Brief Title: Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Official Title: Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
Study ID: NCT01136369
Brief Summary: The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to permanent section Hematoxylin and Eosin (H\&E) and IHC staining.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
John Wayne Cancer Institute, Santa Monica, California, United States
WellStar Health Systems, Marietta, Georgia, United States
Washington University Medical School, Saint Louis, Missouri, United States
Beth Israel Medical Center, New York, New York, United States
Central Carolina Surgery, PA, Greensboro, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Breast Care Specialist, Inc., Westerville, Ohio, United States
Breast Care Specialist, PC, Allentown, Pennsylvania, United States
Nashville Breast Center, PC, Nashville, Tennessee, United States
Dallas Surgical Group, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States