A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 613
- 试验地点
- 20
- 主要终点
- The occurrence of at least one unaddressed positive margin for a subject.
研究概览
简要总结
This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The pathologist at each participating site will be blinded to the study arm to ensure that the pathological assessment is unbiased. Additionally, the subject will be blinded to their randomization until the BREAST-Q questionnaire has been completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ
- •May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion
- •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
- •Previous ipsilateral breast surgery for benign or malignant disease within two years (this includes implants and breast augmentation)
- •Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen
- •Subjects with bilateral disease (diagnosed cancer in both breasts)
- •Participating in any other investigational margin assessment study which can influence collection of valid data under this study
- •Use of cryo-assisted localization
- •Currently lactating
- •Current pregnancy
- •Subjects for whom the specimen margins have been destroyed, damaged, or are otherwise not intact prior to imaging (device arm only) imaging
研究组 & 干预措施
Standard of Care
Lumpectomy with usual intraoperative margin assessment
Device
Imaging of all margins with investigational device
干预措施: Selene (Device)
结局指标
主要结局
The occurrence of at least one unaddressed positive margin for a subject.
时间窗: Pathology report finalization date, usually 3-7 days post-surgery
Within-subject comparison of the occurrence of subjects with at least one positive margin.
次要结局
- False Positive Shaves Per Subject(Pathology report finalization date, usually 3-7 days post-surgery)
- Margin-level effectiveness (Histopathology)(Pathology report finalization date, usually 3-7 days post-surgery)
- The number of unaddressed positive margins per subject.(Pathology report finalization date, usually 3-7 days post-surgery)
- Margin-level effectiveness (National Guidelines)(Pathology report finalization date, usually 3-7 days post-surgery)