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

18 Years
Not Enrolling
Breast Neoplasms, Breast Diseases

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Trial Information

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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patients diagnosed pre-surgically with large or locally advanced (T3 and T4) breast

- 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

- 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.).

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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 staining.

Outcome Time Frame:

2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

December 2008

Related Keywords:

  • Breast Neoplasms
  • Breast Diseases
  • metastasis
  • molecular pathology
  • Breast Neoplasms
  • Breast Diseases
  • Neoplasms



Beth Israel Medical CenterNew York, New York  10003
John Wayne Cancer InstituteSanta Monica, California  90404
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Dallas Surgical GroupDallas, Texas  75235
Washington University Medical SchoolSt. Louis, Missouri  63110
WellStar Health SystemsMarietta, Georgia  30062
Central Carolina Surgery, PAGreensboro, North Carolina  27401
Breast Care Specialist, Inc.Westerville, Ohio  43081
Breast Care Specialist, PCAllentown, Pennsylvania  18104
Nashville Breast Center, PCNashville, Tennessee  37203