Clinical trial · Observational
Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
NCT01136369CI-TRIAL-00003509completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Diseases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OSNA Breast Cancer System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- OSNA Breast Cancer System
- interventionNames
- Device: OSNA Breast Cancer System
Primary outcomes (2)
- 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.
- timeFrame
- 2 years
- measure
- The time required to perform the trial method will be measured and evaluated for intra-operative use.
- timeFrame
- 2 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.).
References
Publications (0)
Data not yet available
No reference posted for this study.