A Phase 0, Open Label Study to Evaluate the Biodistribution and Pharmacokinetics of a Single Intravenous Bolus Dose of PTP-01 in Subjects With Resectable Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Ability of PTP-01 to detect pancreatic ductal adenocarcinoma
研究概览
简要总结
The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.
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
- •subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (PDAC)
- •subject must have adequate renal function
- •ECOG performance status of 0-2
- •women of child-bearing age and men must agree to use contraception prior to and during the study
排除标准
- •subjects receiving any other investigational agents
- •significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
- •pregnant or breastfeeding women
研究组 & 干预措施
PTP-01
single IV bolus dose 24 hours prior to surgery
干预措施: PTP-01 (Drug)
结局指标
主要结局
Ability of PTP-01 to detect pancreatic ductal adenocarcinoma
时间窗: up to 72 hours post dose
requires a signal to background ratio of greater than or equal to 2:1 following a single intravenous bolus of PTP-01
次要结局
- Biodistribution and Binding Characteristics of PTP-01(up to 7 days post dose)
- Clearance of PTP-01(up to 7 days post dose)
- Safety and Tolerability of PTP-01(up to 30 days post dose)