Assessment of Surgical Margins in Breast Cancer Patients Using the Histolog Scanner: A Pilot Prospective Study in the Czech Republic
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction of reoperation rate (%)
研究概览
简要总结
A prospective clinical study investigating the use of the Histolog Scanner for intraoperative assessment of surgical margins in patients undergoing breast-conserving surgery for histologically confirmed breast cancer. The Histolog Scanner operates on the principle of confocal microscopy and enables non-destructive evaluation of specimen margins. The specimen will subsequently be sent for standard histopathological assessment; therefore, the use of this method does not pose any risk to the patient, as the diagnostic and therapeutic pathway for breast cancer will not be altered.
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
- •breast cancer confirmed by core-cut biopsy
- •indication for breast-conserving surgery by a multidisciplinary team
- •surgical therapy in Silesian Hospital in Opava during the study period
排除标准
- 未提供
结局指标
主要结局
Reduction of reoperation rate (%)
时间窗: 4 months
Intraoperative assessment of the surgical specimen using the Histolog Scanner in breast cancer patients undergoing breast-conserving surgery reduces the likelihood of reoperation for an R1 resection, i.e., tumor involvement at the surgical margin.
次要结局
未报告次要终点
研究者
Jan Žatecký
Jan Žatecký, MD, PhD
Silesian Hospital in Opava