Contribution of a Hand-held Gamma Camera (TreCam) to the SNOLL(Occult Breast Lesion Localization Plus Sentinel Node Biopsy) Procedure in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Rate of further surgery for non in sano or inadequate (less than 3 mm security margins) lumpectomy piece's margins.
研究概览
简要总结
In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. The main problem of the surgical management of these lesions is the quality of preoperative identification which determines the quality of surgery and oncological and cosmetic outcomes. For this type of lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed. This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The investigators want to evaluate the potential benefits of using a hand held camera called TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside and in the operating theater.
详细描述
Hypothesis:
The use of intraoperative TReCam improves the surgical procedure by providing relevant information during surgery to reduce the rate of further surgery for inappropriate margins.
Main Objective:
Evaluation of the contribution of TreCam in SNOLL procedure.
Main endpoint:
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam.
Group 2
Patients with a resection of the lesions according to the procedure SNOLL with the use of TReCam.
干预措施: TRECAM (Device)
结局指标
主要结局
Rate of further surgery for non in sano or inadequate (less than 3 mm security margins) lumpectomy piece's margins.
时间窗: Between 2 and 3 weeks
次要结局
- Size, volume and weight of the lumpectomy.(between 2 and 3 weeks)
- Duration of utilization of TreCam at at the end of lumpectomy for acquisition of images of the tumor's bed after removal of the radioactive target and for acquisition of image of the lumpectomy's specimen.(One day)
- Difficulties in data acquisition Using a scale of 4 items : VERY EASY, EASY, DIFFICULT, IMPOSSIBLE(one day)
- Status of resection margins(one day)
- Cosmetics results: 4 point Score(between 2 and 3 weeks)
- Morbidity(between 2 and 3 weeks)
- Volume of resection / tumor volume(between 2 and 3 weeks)
- Duration of utilization of TreCam at at the end of the SLN procedure for verifying the absence of radioactivity.(One Day)
- Duration of utilization of TreCam at The day before surgery and before induction of anesthesia for the location of the breast injection site and SLN.(2 days)
- Duration of utilization of TreCam at each step of the procedure during the breast exploration before lumpectomy.(One day before the surgery)
- Comparison between imaging data provided in preoperative time by TreCam and by standard LS: image's quality, location of the injection's site, location and number of SLN.(One day)