Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
研究概览
简要总结
This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells. PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC) as confirmed by postsurgical or biopsy histology.
SECONDARY OBJECTIVES:
I. To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of Cu-64-TP3805.
TERTIARY:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Must have diagnosis of urothelial cancer
- •Scheduled for extirpative surgery or biopsy of suspected metastatic lesion
- •Women of reproductive potential must have a urine pregnancy test day of injection
- •Men of reproductive potential must use condoms
排除标准
- •Pregnancy or lactation
- •Known allergic reactions to components of the study product(s)
- •Treatment with another investigational drug or other intervention with 24 hours of injection
- •Must not have had an injection of a radioisotope 24 hours prior to exam
研究组 & 干预措施
Diagnostic (Copper Cu 64 TP3805 PET/CT)
Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later.
干预措施: Copper Cu 64 TP3805 (Drug)
Diagnostic (Copper Cu 64 TP3805 PET/CT)
Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (Copper Cu 64 TP3805 PET/CT)
Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later.
干预措施: Computed Tomography (Procedure)
结局指标
主要结局
Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
时间窗: Up to 4 weeks post-intervention
For imaging, positive lesions will be deemed those which shall have standard uptake volume of 1.1 or greater. The results shall be correlated with post-surgical histology
次要结局
- Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples(Up to 120 minutes post injection)
- Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value(Up to 120 minutes post injection)