Prospective Pilot Cohort Study to Assess Early Diagnostic Utility of Hyper-Spectral Endoscopy for Detection of Neoplasia in Barrett's Oesophagus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Contrast of neoplastic vs non-neoplastic Barrett's
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of hyperspectral endoscopic imaging to distinguish neoplasia from non-dysplastic Barrett's oesophagus in vivo. The main outcome measures are: 1) Classification of spectral patterns corresponding to neoplastic vs non-neoplastic Barrett's; 2) Image quality assessed by the endoscopist by VAS rating the level of confidence in delineating the area of interest; 3) Time to perform hyperspectral imaging; 4) Quantification of molecular biomarkers in endoscopic areas with neoplastic spectral patterns.
Participants will firstly undergo a standard endoscopy, followed by another endoscopy using the experimental HySe device. Subsequently, patients will receive biopsies according to Seattle protocol, and up to 6 additional (optional) snap frozen research biopsies.
详细描述
This trial is designed to evaluate the feasibility of hyperspectral endoscopic imaging in vivo.
The team has developed a custom hyperspectral endoscope based around a commercially available, standard-of-care endoscopy stack from Olympus (Tokyo, Japan). In this system, the original gastroscope, video processor and display are used with a modified light source that incorporates a laser with tunable wavelength for illuminating the scene through the endoscope. A live video feed from the gastroscope is displayed on the endoscopy theatre monitors and can be acquired and saved in the native video acquisition system.
Given that it is essential in the pilot study to assess the detection of neoplastic lesions in a small patient cohort, we will artificially enrich for patients with early neoplasia by including patients with previously recognized early neoplasia within Barrett's oesophagus (high grade dysplasia and intramucosal adenocarcinoma). These patients will receive a clinically indicated endoscopy to be assessed to determine eligibility for endoscopic treatment, and imaging would be done at this time point. This will allow the team to have sufficient number of outcomes to have preliminary data on diagnostic accuracy and be able to power future studies in non-enriched patient cohorts.
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
- •Male or female subjects over 18 years.
- •Previous diagnosis of Barrett's oesophagus, with an endoscopic length of at least 2 cm if circumferential (C≥2 according to Prague classification) or 3 cm if not circumferential (maximal extent M≥3, according to Prague classification).
- •Previous diagnosis of oesophageal glandular dysplasia or early oesophageal adenocarcinoma for consideration of endoscopic therapy.
排除标准
- •History of oesophageal stricture precluding passage of the endoscope.
- •Pregnancy, or planned pregnancy during the course of the study.
- •Currently breastfeeding.
- •Any history of oesophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B & C) or evidence of varices on initial treatment endoscopy.
- •Any history of oesophageal surgery, except for uncomplicated fundoplication.
- •History of coagulopathy, with INR>1.3 and/or platelet count of <75,
- •On clopidogrel, and/or warfarin for high risk condition and unable to withhold temporarily the medication.
结局指标
主要结局
Contrast of neoplastic vs non-neoplastic Barrett's
时间窗: Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure
Pixel intensity value at 16 different wave lengths in endoscopic areas of interest as compared with standard-of-care RGB white light endoscopy
次要结局
- Time to perform hyperspectral imaging(During the intervention)
- Image quality of Hyper-Spectral Endoscopy in vivo(Immediately after the intervention)
- Quantification of molecular biomarkers in endoscopic areas with neoplastic spectral patterns(Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure)
- Image quality of Hyper-Spectral Endoscopy after post-hoc analysis(Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure)
研究者
Massimiliano di Pietro, MD
Principal Investigator
University of Cambridge