Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Percentage of subjects with positive margins post-op
研究概览
简要总结
Multi center, pivotal prospective, randomized clinical trial
The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.
详细描述
ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify DCIS or invasive cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.
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
- None
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
- •Patients who are female (genotype)
- •Patients aged above 18 years, inclusive
- •Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
- •Patients treated with neoadjuvant endocrine therapy may be enrolled
排除标准
- •Patients currently receiving chemotherapy
- •Patients having prior ipsilateral surgical treatment for breast cancer
- •Patients who have had radiation therapy for ipsilateral breast cancer or for other malignancy that includes breast tissue in the radiation field (e.g. Hodgkin's lymphoma)
- •Patients who have breast implants
- •Patients who are pregnant and/or lactating
- •Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.
结局指标
主要结局
Percentage of subjects with positive margins post-op
时间窗: In the operating room compared to pathology assessment within 1 week post-op
The percentage of patients with DCIS or invasive cancer involved margins as determined by pathology PM after evaluation with SoC or SoC+ClearEdge.
次要结局
- FN and FP rates(within weeks post-op)