Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging
研究概览
简要总结
This is an open-label study in adults to determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients 18 years of age and older of any sex.
- •Have a primary diagnosis, or a high clinical suspicion, of gastroesophageal adenocarcinoma based on CT (computed tomography)/PET (positron emission tomography) or other imaging (Cohort 1) or diagnosis of appendiceal adenocarcinoma with a high clinical suspicion of peritoneal carcinomatosis (Cohort 2).
- •Have an indication for surgical intervention for gastroesophageal tumor resection or diagnostic laparoscopy for assessment of peritoneal disease burden.
- •Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX.
- •Willingness of research participant to give written informed consent.
排除标准
- •Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject.
- •History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
- •History of allergy to any of the components of CYTALUX™ (pafolacianine) injection.
- •Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule.
- •Known sensitivity to fluorescent light.
- •Women of childbearing potential who are pregnant or plan to become pregnant during the study.
研究组 & 干预措施
CYTALUX™ (pafolacianine)
Enrolled subjects will be dosed with 0.025 mg/kg CYTALUX™ (pafolacianine) injection intravenously, with the hour-long infusion completing from 1 hour to up to 24 hours prior to imaging for the planned surgery.
干预措施: CYTALUX™ (pafolacianine) (Drug)
结局指标
主要结局
Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging
时间窗: 12 months
Determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal) in at least 70% of the patients.
次要结局
- Number of Lesions(12 months)
研究者
Miguel Burch
Principal Investigator
Cedars-Sinai Medical Center