Pilot Study Assessing the Technical Efficacy of Computed Tomography Urography (CTU) vs Intravenous Urography (IVU) With Particular Focus on Patients at Risk of Urothelial Tumors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- CTU to IVU Technical Performance Comparison: Opacification + Ability to Visualize Urothelial Segments
研究概览
简要总结
The goal of this clinical research study is to use computed tomography urography (CTU) scans and intravenous urography (IVU) scans to check the status of urothelial cancer, in order to try to learn the level of effectiveness of possibly using CTU by itself in future patients.
详细描述
Background for the Study:
Currently, IVU is used to detect urothelial tumors and then computed tomography (CT) scans are performed after that, to check the status of the disease. This is typically done every 3 months for the first 2 years after diagnosis, and then every 6 months for the next 2 years. Researchers want to learn if this current routine method of using 2 diagnostic procedures can be replaced with CTU alone, in future patients.
CTU uses the same scanner machine as CT scans do. The difference between these 2 types of scans is that in addition to collecting the same type of images and information that CT scans do, CTU may also allow the doctor to look at the lining of the tubes that carry urine from the bladder. Looking at the lining of these tubes is something that IVU is used for, and researchers want to find out if CTU can also be used for this purpose.
Study Procedures:
If you are found to be eligible to take part in this study, you will have a CTU procedure performed at least a day before or after your routine IVU. If your doctor has ordered a CT of your abdomen and pelvis and IVU, the CTU will be performed instead of a routine CT scan of the abdomen and pelvis that would normally occur. If your doctor has ordered just a CTU, you will have an IVU as well.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo IVU using digital tomosynthesis and staging abdomino-pelvic CT as part of their routine care will be invited to participate in this study.
- •Patients who have been referred for CTU will also be invited to participate in the study.
- •Such patients will typically
- •Have histologically proven TCC, or
- •Have bladder tumors of Stage ≥ T3, or
- •Had cystectomies for bladder cancer, or
- •Upper tract TCC.
- •>18 years age.
- •Written informed consent will be obtained from patients.
排除标准
- •Elevated serum creatinine of >2
- •Allergy to intravenous CT contrast media
- •Ureteral stint present or removed within six weeks
- •Women of child bearing potential
研究组 & 干预措施
CTU + IVU
CTU = Computed Tomography Urography + IVU = Intravenous Urography
干预措施: Computed Tomography Urography (CTU) (Device)
CTU + IVU
CTU = Computed Tomography Urography + IVU = Intravenous Urography
干预措施: Intravenous Urography (IVU) (Other)
结局指标
主要结局
CTU to IVU Technical Performance Comparison: Opacification + Ability to Visualize Urothelial Segments
时间窗: 2 Years
Comparison of relative technical performance of computed tomography urography (CTU) to intravenous urography (IVU) using digital tomosynthesis, in terms of visualization and diagnostic quality of segments of the upper urinary tract.
次要结局
未报告次要终点