Evaluation of the Feasibility and Efficacy of Lidocaine Mucilage-ICG as an Optical Agent to Detect Cancer Tissue Delineation During Breast-conserving Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Positive margin rate
研究概览
简要总结
Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins at final histopathology. Currently available modalities used for intraoperative surgical margin assessment all have specific limitations. In order to improve intraoperative tumor localization and surgical margin assessment in BCS, we developed a fluorescent tracer, the Lidocaine mucilage-ICG tracer, which could be locally injected and detected by fluorescent camera systems during operation. In this study, we aim to evaluate the efficacy of Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female at least 18 years old
- •Histologically or cytologically confirmed breast carcinoma
- •Patients planned to receive a breast-conserving surgery
- •Patients received a preoperative breast magnetic resonance imaging
- •Informed consent form understood and signed
- •Patient agrees to all follow-up visits
- •Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the surgery
排除标准
- •Psychiatric or other condition that may interfere with the study
- •Known allergy or contraindication to any study drug
- •Patients received neoadjuvant therapies
- •Patients received an excision biopsy of the tumor
- •Breast feeding period
- •Pregnant (female of childbearing potential only)
研究组 & 干预措施
Efficacy of Lidocaine mucilage-ICG
Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation
干预措施: Lidocaine mucilage-ICG (Drug)
结局指标
主要结局
Positive margin rate
时间窗: 7 days
The percentage of patients with a positive margin out of the participants
Margin width
时间窗: 7 days
The distance between tumor and margin on the gross specimen
次要结局
未报告次要终点
研究者
Si-Qi Qiu
Principal Investigator
Shantou Central Hospital