Evaluation, for Patients Requiring a Liver Cancer Surgery, of the Use of Fluorescence Imaging Device: Faisability and Efficiency of Lesional and/or Anatomical Marking
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- First step: assess the feasibility and the acceptability of Fluobeam
研究概览
简要总结
This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess the faisability and the capabilities of fluorescence imaging in hepatic surgery, and specially to help the surgeon while performing liver surgery.
This study will be performed on patient intended to undergo a liver cancer surgery.It will contain three steps, assessing the following items:
- Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical surgical conditions and validate the data obtained in the preclinical phase,
- Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic lesions,
- Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding per-hepatectomy.
3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the third step.
Patients will be followed during 4 weeks after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Affected of hepatic cancerous lesions whatever they are
- •Requiring a one or two steps hepatectomy by laparotomy
- •ECOG performance status (PS)≤ 2
- •Mandatory affiliation to health security insurance
- •Written informed consent
排除标准
- •With a contraindication or hypersensitivity to ICG administration in medical history
- •Having already undergone a major hepatic surgery (more than three segments) or major biliar surgery (context of major iterative hepatic surgery)
- •Unable to be followed during the duration of the study, for social, family, geographical or psychological reasons
- •Pregnant or breast-feeding woman (urinary strip must be negative at the time of the inclusion in the study for women in age to procreate)
结局指标
主要结局
First step: assess the feasibility and the acceptability of Fluobeam
时间窗: During surgery on day 0
* The ability to detect fluorescence * The ability to investigate the mobilized parenchyma * The ability to use the medical device following requested asepsis procedures * Surgeon satisfaction * Nurse satisfaction
Second step: assess the rate of patients in whom, all of the lesions (superficial/deep) will be detected by means of the Fluobeam medical device in peroperative or in postoperative.
时间窗: During surgery on day 0
Third step: assess the rate of patients in whom, among the 7 liver segments, the surgeon will be able to selectively target a predefined area.
时间窗: During surgery on day 0
次要结局
- First step: assess the ability to visualize the fluorescent anatomical areas(During surgery on day 0)
- First step: Quantify the fluorescence(After the surgery, on day 0)
- Second step: assess the ability to detect tumor lesions which were not previously known.(During surgery on day 0)
- Third step: assess the ability to detect tumor lesions which were not previously known.(During surgery on day 0)
- Third step: assess the ability of the medical device to detect tumor lesions which were previously known.(On day 0)
- Second step: assess the rate of modifications of the surgical plan.(During surgery on day 0)
- Second step: Quantify the fluorescence.(After the surgery, on day 0)
- Second step: assess the number of asepsis due to Fluobeam(During surgery on day 0)
- Third step: assess the ability to administer two doses of ICG in the same patient(On day 0)
- Second step: assess the quality of the resection margins.(After the surgery on day 0)
- First step: assess the ability to review saved data(After the surgery, on day 0)
- Second step: assess the depth limit of detection of the fluorescence.(After the pathology analysis on day 0)
- Third step: quantify the fluorescence.(After the surgery on day 0)
- Third step: assess the number of asepsis due to Fluobeam(During surgery on day 0)