First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Assessment of safe administration of 18F-αvβ6-BP
研究概览
简要总结
This clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well it works in imaging patients with primary or cancer that has spread to the breast, colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may improve the ability to locate cancer in the body.
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety, biodistribution and dosimetric properties of 18F-alphavbeta6-binding peptide (BP) in normal tissues and malignancies in cancer patients and correlate concordance with alphavbeta6 expression.
OUTLINE:
Patients receive 18F-alphavbeta6-BP intravenously (IV) and then undergo positron emission tomography (PET) scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.
After completion of study, patients are followed up for up to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
- •Will sign the Institutional Review Board (IRB)-approved consent form
- •Able to remain motionless for up to 30-60 minutes per scan
排除标准
- •Creatinine > 2 x upper limit of normal
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 x upper limit of normal
- •Life expectancy < 3 months (mo)
- •Women who are pregnant or breast-feeding
- •Patients who cannot undergo PET/compute tomography (CT) scanning
- •Lack of availability for follow-up assessments
- •Participation in another clinical trial involving an investigational agent within 4 weeks of enrollment
研究组 & 干预措施
18F-αvβ6-BP
Patients receive 18F-alphavbeta6-BP IV and then undergo 4 PET scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.
干预措施: 18F-αvβ6-BP (Drug)
结局指标
主要结局
Assessment of safe administration of 18F-αvβ6-BP
时间窗: Up to 6 months
Assessed by measures and/or changes in a given vital sign
次要结局
- Measurement of 18F-αvβ6-BP accumulation in tumors(Up to 6 months)
- Level of αvβ6-BP expression in tumors(Up to 6 months)
研究者
Julie L. Sutcliffe, Ph.D
Principal Investigator
University of California, Davis