Breast Cancer Clinical Trial
Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
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.
Male or Female patients, over the age of 18, diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel node dissection.
Patients who have read and understand the informed consent form and are capable and willing to provide written informed consent.
Patients diagnosed pre-surgically with large or locally advanced (T3 and T4) breast cancers.
Patients diagnosed with inflammatory breast cancer.
Patients diagnosed with ductal carcinoma in situ (DCIS) when breast conserving is to be done.
Patients who are pregnant, as confirmed by a patient/treating physician interview.
Patients with suspicious palpable axillary lymph nodes.
Patients currently being treated for or previously diagnosed with, another type of carcinoma.
Patients who have undergone prior non-oncologic breast surgery or axillary surgery.
Patients who have received pre-operative systemic therapy.
Patients who are incapable of providing written informed consent.
Patients who have been judged to be inappropriate by a medical care provider (i.e. surgeon, oncologist, pathologists, etc.).
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There are 11 Locations for this study
Santa Monica California, 90404, United States
Marietta Georgia, 30062, United States
Saint Louis Missouri, 63110, United States
New York New York, 10003, United States
Greensboro North Carolina, 27401, United States
Winston-Salem North Carolina, 27157, United States
Westerville Ohio, 43081, United States
Allentown Pennsylvania, 18104, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
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