NCT01136369已完成不适用
Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 496
- 试验地点
- 11
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.).
结局指标
主要结局
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.
时间窗: 2 years
The time required to perform the trial method will be measured and evaluated for intra-operative use.
时间窗: 2 Years
次要结局
未报告次要终点
研究者
研究点 (11)
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