NCT01368744已完成不适用
Intraoperative Examination of Sentinel Lymph Nodes: Comparison of the OSNA Breast Cancer System to Extensive Frozen Section Histopathology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Prospectively assess the concordance and performance of the OSNA Breast Cancer System with an extensive intraoperative frozen section protocol for SLNs removed using standard SLN biopsy procedures from breast cancer subjects.
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 an extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.
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;
- •18 years of age or older;
- •Diagnosed pre-surgically with T1 or T2 breast cancer without clinical evidence of axillary lymph node involvement and scheduled for surgery including sentinel lymph node dissection;
- •Subjects (or the subjects' legal representatives) who have read, understood to the best of their ability and signed the informed consent form.
排除标准
- •Subjects diagnosed pre-surgically with large or locally advanced (T3 & T4) breast cancer;
- •Pregnant subjects, confirmed by interview with either subject or treating physician;
- •Subjects diagnosed with inflammatory breast cancer;
- •Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done;
- •Subjects with clinically suspicious, palpable axillary lymph nodes;
- •Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma; Subjects with non-invasive carcinoma of the Cervix may also be included in this study.
- •Subjects who have received pre-operative systemic therapy;
- •Subjects who are incapable of providing written informed consent;
- •Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
- •Subjects participating in other clinical studies where the SLN evaluation will be negatively impacted by this study.
结局指标
主要结局
Prospectively assess the concordance and performance of the OSNA Breast Cancer System with an extensive intraoperative frozen section protocol for SLNs removed using standard SLN biopsy procedures from breast cancer subjects.
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence ImagingEndometrial CancerCervical CancerNCT01673022Indiana University430
已完成
不适用
Sentinel Lymph Node Detection in Prostate Surgery by LaparoscopyProstatic NeoplasmsNCT01296217Centre René Gauducheau24
Unknown
不适用
The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial CarcinomaEndometrial CarcinomaLymphadenectomyNCT03877627Second Affiliated Hospital of Wenzhou Medical University60
已完成
不适用
Intraoperative detection of sentinel lymph nodes in lung cancerlung cancerJPRN-UMIN000003035Osaka International Cancer Institute20
已完成
2 期
A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric CancersPediatric Patients With Solid TumorsNCT02910726Memorial Sloan Kettering Cancer Center6