NCT01886820Unknown3 期
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology
Navidea Biopharmaceuticals15 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 290
- 试验地点
- 15
- 主要终点
- Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology
研究概览
简要总结
To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects will be at least 21 years of age.
- •Subjects will have a life expectancy of approximately 6 months
- •Subject health is adequate as determined by the investigator to receive [18F]NAV4694
- •Female subjects will not be of child-bearing potential or will have a negative urine pregnancy test on day of [18F]NAV4694 injection.
- •Must exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures. This includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour.
- •Subjects must be willing to donate their brains for post mortem examination upon death (this consent can be obtained in the manner specific to the country/region involved).
- •Subjects have been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (LAR) (for individuals with dementia).
排除标准
- •Scheduled for surgery and/or another invasive procedure within the time period of up to 7 days after [18F]NAV4694 injection.
- •Has severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI that prohibits sampling of the required pre-specified ROIs.
- •Has any history of any transmissible spongiform encephalopathy (prion disease).
- •Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131-I) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration.
- •Is allergic to the investigational product or any of its constituents.
研究组 & 干预措施
[18F]NAV4694
Experimental
Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once
干预措施: [18F]NAV4694 (Drug)
结局指标
主要结局
Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology
时间窗: 6 Months
次要结局
- Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology(6 Months)
- Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology(6 Months)
- Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology(6 Months)
- Incidence of adverse events(6 months)
研究者
研究点 (15)
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