Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of dysplastic and cancerous lesions identified under white light and under fluorescence
研究概览
简要总结
This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.
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
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or female, aged 18 years or above
- •Participants undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy or transanal endoscopic microsurgery (TEMS), including robotic assisted TEMS
- •In the investigator's opinion, is able and willing to comply with all study requirements
- •Exclusion Criteria
- •Participant who is unable to unwilling to give informed consent
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. If there is an uncertainty regarding whether a woman could be pregnant, then they will be excluded from the study
- •Participants with known egg allergies, ovalbumin allergy and soya allergies
排除标准
- 未提供
研究组 & 干预措施
Fluorescent Lectin Application
Fluorescein conjugated wisteria floribunda will be sprayed onto the colonic surface during colonoscopy or TEM surgery.
干预措施: Fluorescent Lectin Application (Drug)
结局指标
主要结局
Number of dysplastic and cancerous lesions identified under white light and under fluorescence
时间窗: During procedure
Number of lesions identified under white light colonoscopy will be compared to the number of lesions identified under fluorescence.
Signal to background ratios of identified colonic lesions under white light and under fluorescence
时间窗: During procedure
This outcome measure compares the fluorescence signal of lesions identified during colonoscopy.
次要结局
- Number of dysplastic and cancerous lesions identified under white light and fluorescence in different subgroups(12 months)
- Resection margin of of lesions undergoing TEMS resection under white light and under fluorescence.(12 months)
研究者
TREVOR MING-YEE YEUNG
Academic Clinical Lecturer
University of Oxford