NCT01253213已完成早期 1 期
Exploratory Clinical Trial Using BR55 Targeted Ultrasound Contrast Agent in the Detection of Prostate Cancer by Molecular Imaging of VEGFR2
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- BR55 sensitivity assessment
研究概览
简要总结
The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2 expression in human prostate by ultrasound molecular imaging.
This will be compared with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient, age ≥ 40 years old
- •Has a histology proven focal prostate cancer lesion
- •The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration
- •Provides written Informed Consent and is willing to comply with protocol requirement
排除标准
- •Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100μg) according to the indication of the EMEA guideline M3 for this type of study
- •Has documented acute prostatitis or urinary tract infections
- •Is known to suffer from stable angina pectoris and/or proven coronary disease, or to have symptoms suspicious of coronary disease
- •With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts
- •Has had severe cardiac rhythm disorders within the last 7 days
- •Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- •Has received a prostate biopsy procedure within 30 days before admission into this study
- •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
- •Is determined by the Investigator that the patient is clinically unsuitable for the study.
- •Is incapable of understanding the language in which the information for the patient is given
- •Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;
研究组 & 干预措施
BR55
Experimental
干预措施: BR55 (Drug)
结局指标
主要结局
BR55 sensitivity assessment
时间窗: Day 1
Assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).
次要结局
- BR55 specificity assessment(Day 1)
研究者
研究点 (1)
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