Determining the Safety and Feasibility of Optical Coherence Tomography and Near Infrared Fluorescence: a Prospective Pilot Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT
研究概览
简要总结
To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and the esophagus) there is a need for better endoscopic visualization and the ability for targeted biopsies. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labelling the VEGF-A-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye bevacizumab-800CW (IRDye800CW). In several phase I studies and phase II studies, either completed or currently running, in the UMCG, the use of VEGF-A-guided near-infrared (NIR) fluorescence molecular endoscopy (FME) in combination with high-definition white light endoscopy (HD-WLE) shows an improved detection rate of early premalignant lesions. In this study the safety and feasibility of a next generation imaging system will be tested. This system uses immune optical coherence tomography (immuno-OCT) and near infrared fluorescence (NIRF) with the targeted tracer (Bevacizumab-800CW) for improvement of the detection of dysplastic lesions in Barret's esophagus (BE) and colorectal polyp detection. The system provides more depth information and can eventually be used without the guidance of the regular endoscopy system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Indication for a therapeutic endoscopy procedure (EMR or ESD);
- •Age ≥ 18;
- •Written informed consent.
排除标准
- •Patients younger than 18 years old;
- •Submucosal and invasive esophageal adenocarcinoma (EAC) or colorectal carcinoma (CRC);
- •Radiation therapy for esophageal or colorectal cancer;
- •History of infusion reactions to Bevacizumab or other monoclonal antibodies;
- •Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer;
- •Non-adjustable hypertension;
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
- •Pregnancy or breastfeeding; a negative pregnancy test must be available for women of childbearing potential.
研究组 & 干预措施
OCT with IV in colorectal polyps
OCT and FME imaging of Barret and colorectal lesions during endoscopy.
干预措施: Bevacizumab-800CW (Drug)
结局指标
主要结局
Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT
时间窗: during procedure
Any events related to the device.
次要结局
- Validation of OCT system: Ex vivo fluorescence imaging(During procedure)
- validation of OCT system: ex vivo immuno-OCT imaging(During procedure)
- Validation of the immuno-OCT system: FME(During procedure)
- validation of OCT system: immunohistochemistry(Once, as soon as possible after procedure)