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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

John Wayne Cancer Institute, Santa Monica, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.).

Treatment and study plan

OSNA Breast Cancer System

Device

For in vitro diagnostic use only.

The OSNA Breast Cancer System is an automated semi-quantitative, in vitro diagnostic test for the rapid detection of greater than (>) 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes and to aid in patient staging. An assay positive + or ++ result indicates the presence of metastasis (> 0.2 mm). An assay positive ++ result predicts the presence of macrometastasis (> 2 mm).

Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Sysmex lymph node cutting scheme, is required.

Primary outcomes

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.

Time frame: 2 years
The time required to perform the trial method will be measured and evaluated for intra-operative use.

Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

Sysmex America, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jun 3, 2010
Registry last updated: Jun 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed