Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- SFE ability to detect dimer by fluorescence T/B ratio
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) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). 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
- •Has known or suspected Barrett's esophagus
- •Scheduled for a clinically-indicated, upper endoscopy
- •Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
- •Age 18 to 100 years
- •Willing and able to sign informed consent
排除标准
- •Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives
- •Subjects on active chemotherapy or radiation treatment
- •Pregnant or trying to conceive
研究组 & 干预措施
Esophagus sprayed with KSP/QRH dimer
Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe
干预措施: KSP/QRH dimer (Drug)
结局指标
主要结局
SFE ability to detect dimer by fluorescence T/B ratio
时间窗: During and immediately after procedure, generally no more than 2 hours
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using fluorescence tumor-to-background (T/B) ratio
Binding of KSP/QRH dimer to EGFR and HER2
时间窗: During and immediately after procedure, generally no more than 2 hours
Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background
SFE ability to detect dimer by SNR
时间窗: During and immediately after procedure, generally no more than 2 hours
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using signal-to-noise ratio (SNR)
SFE ability to detect dimer with contrast
时间窗: During and immediately after procedure, generally no more than 2 hours
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using contrast
次要结局
未报告次要终点
研究者
Danielle Kim Turgeon
Professor of Internal Medicine
University of Michigan