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Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis from Breast Cancer

Time frame of study:		Ongoing
Location of Study:		Beth Israel Medical Center
Contact:		Continuum Cancer Center Research Program (212) 844-6286

Summary:
The following study will evaluate a new instrument designed to analyze the results of a sentinel node biopsy. This procedure is standard practice during Breast Cancer treatment, as research has shown that breast cancer first spreads to a few axillary lymph nodes before metastasizing. Current methods for rapidly analyzing sentinel node biopsies during the breast cancer operation (such as frozen section) are not as accurate as physicians would like, leading to additional surgeries to remove previously undetected metastasic cancers. This new device may yield rapid detection of lymph node metastasis, and may be more accurate than current methods. It uses a technology called OSNA (One-Step Nucleic Acid Amplification) and works by concentrating and then analyzing cell contents to determine if cancer cells are present. The new device was developed by Sysmex.

Eligibility:
Male or non-pregnant, female patients, over the age of 18, diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel node dissection, and who meet the inclusion/exclusion criteria for this protocol. Please call for more information.

Benefits and/or Compensation:
There is no monetary compensation for this study. The information gathered from this study may be beneficial to future patients.