2023-508316-27-00招募中4 期
Preoperative Indocyanine Green administration increases intraoperative detection of Liver Tumors in Imaging-guided surgery. A phase IV clinical trial.
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca3 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2024年2月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 173
- 试验地点
- 3
- 主要终点
- Quantify the intraoperative detection of liver tumors using IOUS and ICG
研究概览
简要总结
• To analyze the detection of liver tumors using indocyanine green fluorescence uptake in combination with intraoperative ultrasonography and preoperative imaging test • To develop a machine-learning algorithm to detect liver tumors with indocyanine green by photographic analysis.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Livergreen
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with liver tumors with an indication for minimally invasive surgery, evaluated by the hospital’s multidisciplinary liver tumor board (MDTB).
- •Preoperative imaging test (contrast-enhanced liver MRI, multiphasic contrast-enhanced abdominal CT, or contrast-enhanced PET-CT) performed prior to the surgical intervention according to usual clinical practice of each site.
- •≥18 years old
- •Absence of exclusion criteria and able to provide consent for data collection and analysis
排除标准
- •Emergency surgery
- •Patients in which ICG is contraindicated (one condition will be enough for excluding the patient):
- •previous history of iodine hypersensitivity;
- •patients with renal failure (GFR <60 mL/min/1.73 m2); 3 uremic syndrome;
- •clinical hyperthyroidism;
- •autonomic thyroid adenomas; or
- •focal and diffuse autonomic abnormalities of the thyroid gland.
- •Previous liver surgery
结局指标
主要结局
Quantify the intraoperative detection of liver tumors using IOUS and ICG
Quantify the intraoperative detection of liver tumors using IOUS and ICG
次要结局
未报告次要终点
研究者
Tamara del Río
Scientific
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
研究点 (3)
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