A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
研究概览
简要总结
Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results
详细描述
This multi-centre, open label, prospective, pilot study was designed to assess the ability of BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, age between 50-70 years old
- •Increased Prostate-Specific Antigen (PSA) level >4 ng/mL
- •Known prostate cancer
- •Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable)
- •Provided written informed consent and willing to comply with protocol requirements
排除标准
- •Documented acute prostatitis or urinary tract infections
- •Known to suffer from stable angina pectoris and/or proven coronary disease, or have symptoms suspicious of coronary disease
- •History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts
- •Severe cardiac rhythm disorders within the last 7 days
- •Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
- •Received a prostate biopsy procedure within 30 days before admission into the study
- •Determined by investigator to be clinically unsuitable for the study
- •Participated in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days
研究组 & 干预措施
BR55
All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...
干预措施: BR55 (Drug)
结局指标
主要结局
Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
时间窗: Within 30 minutes after administration of BR55
To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
次要结局
- Number of Participants With Adverse Events(24 hours post-dose)