Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patients With All Positive Margins Correctly Identified With the Device
研究概览
简要总结
This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years of age or older
- •Signed informed consent form
- •Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
- •Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure
排除标准
- •Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- •Neoadjuvant systemic therapy
- •All T4 tumors
- •Previous radiation in the operated breast
- •Prior surgical procedure in the same quadrant
- •Implants in the operated breast
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
结局指标
主要结局
Patients With All Positive Margins Correctly Identified With the Device
时间窗: one week after surgery
In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").
Number of Margins With False Positive Device Readings
时间窗: one week after surgery
次要结局
未报告次要终点