Phase I In-vivo Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Validate the binding of the peptides using the SFE
研究概览
简要总结
The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the scanning fiber endoscope(SFE) multiplexed imaging system. This study will combine the use of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in the esophagus for use as novel imaging agents to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1 study will be used to provide early evidence of efficacy for the topical application of a panel of two peptides that bind to molecular targets that are specific for esophageal dysplasia. A panel is needed because cancer in the esophagus is genetically heterogeneous. The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known or suspected Barrett's esophagus
- •Scheduled for a clinically-indicated upper endoscopy
- •Medically cleared for the procedure
- •Willing and able to sign informed consent
排除标准
- •Known allergy or negative reaction to the near infrared fluorophores Cy5, li-cor IRDye800CW, or derivatives
- •One active chemotherapy or radiation treatment
- •Pregnant or trying to conceive
研究组 & 干预措施
Multiplexed heptapeptides
QRH & KSP sprayed onto area of interest and imaged before and after application
干预措施: Multiplexed heptapeptides (Drug)
结局指标
主要结局
Validate the binding of the peptides using the SFE
时间窗: 1 year
The binding of the fluorescent-labeled peptides (QRH-882260 and KSP-910638G) that bind to EGFR and HER2 using an SFE molecular imaging system (SFE) determined using the tumor-to-background ratio for fluorescence intensities
次要结局
- Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)(1 year)
- Use of the SFE to detect QRH and KSP via tumor-to-background ratio(1 year)
- Use of the SFE to detect QRH and KSP via contrast(1 year)
研究者
Danielle Kim Turgeon
Professor of Internal Medicine
University of Michigan