NCT04242277已完成不适用
A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.
Perimeter Medical Imaging2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2020年8月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- WF-OCT image acquisition of excised lumpectomy tissue margins
研究概览
简要总结
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
详细描述
Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.
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
- •Age 18 years or older
- •Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery
- •May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation)
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Metastatic cancer (Stage IV)
- •Lobular carcinoma as primary diagnosis
结局指标
主要结局
WF-OCT image acquisition of excised lumpectomy tissue margins
时间窗: 1 year
This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins.
次要结局
未报告次要终点
研究者
研究点 (2)
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