The Impact of Surgeon-Interpreted Intraoperative Margin Assessment During Breast Conserving Surgery on Postoperative Treatment
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
研究概览
简要总结
To learn if Pegulicianine Fluorescence-Guided Surgery (pFGS), which is part of the Lumicell Direct Visualization System, and Digital Breast Tomosynthesis (DBT) can improve the identification of tumor margins during a partial mastectomy and decrease the need for a second surgery.
详细描述
Primary Objectives:
-To determine if surgeon interpretation of pFGS and DBT has a higher specificity compared to SEP, resulting in fewer excisions of additional tissue unnecessarily
Secondary Objectives:
- To determine if surgeon evaluation of segmental mastectomy margins using pFGS and DBT is associated with better patient- and physician-reported cosmesis
- To determine if surgeon interpretation of pFGS and DBT results in a lower rate of positive margins after BCS compared to SEP
- To determine if surgeon interpretation of pFGS and DBT has a shorter operative time compared to SEP.
- To determine if surgeon interpretation of pFGS and DBT results in less delays in receipt of adjuvant treatment and the reduction of targeted volume of radiation therapy or omission of radiation altogether
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
- •We plan to enroll 175 patients.
- •Women aged 18 years or older with a breast cancer diagnosis at any stage who will undergo a segmental mastectomy, regardless of receipt of neoadjuvant therapy.
排除标准
- •Multi-site segmental mastectomies within the same breast
- •Participants without a cancer diagnosis
- •Participants from vulnerable populations including minors, pregnant women, and/or cognitively impaired adults.
研究组 & 干预措施
Intraoperative Margin Assessment
Utilizing Intraoperative Margin Assessment during the breast conserving surgery, using pFGS as well as DBT.
干预措施: Breast Conserving Therapy (Procedure)
Intraoperative Margin Assessment
Utilizing Intraoperative Margin Assessment during the breast conserving surgery, using pFGS as well as DBT.
干预措施: Pegulicianine Fluorescence-Guided Surgery (Procedure)
Intraoperative Margin Assessment
Utilizing Intraoperative Margin Assessment during the breast conserving surgery, using pFGS as well as DBT.
干预措施: Digital Breast Tomosynthesis (Procedure)
结局指标
主要结局
safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
时间窗: Through study completion; an average of 1 year.
次要结局
未报告次要终点