a Prospective In-vivo Human Study to Assess the Diagnostic Accuracy of Optical Coherence Tomography for Diagnosis and Staging of Upper Urinary Tract Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Specificity of 1300nm OCT in grading and staging UUT-UC
研究概览
简要总结
The purpose of this study is to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma.
详细描述
Minimal invasive endoscopic treatment for Upper Urinary Tract Urothelial Carcinoma (UUT-UC) has been accepted as a treatment option instead of radical nephroureterectomy for patients with low grade, low stage disease. For this reason, information on tumour stage and grade is important for a clinical decision. Until now,diagnostic ureterorenoscopy combined with histology/cytology is the gold standard. Unfortunately, histology/cytology is often inconclusive.
Optical Coherence Tomography is a new high resolution imaging technique that has potential to provide the urologist real time per-operative information of grade and stage of the disease.
In this study the investigators aim to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma. Secondary objectives are inter-observer variability of 1300 nm OCT in the diagnosis of UUT-UC and optical properties of cancerous and healthy ureter and collecting system tissue in vivo in humans.
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
- •Candidate for diagnostic or therapeutic ureterorenoscopy
- •Signed informed consent
排除标准
- •No signed informed consent
研究组 & 干预措施
optical coherence tomography
A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)
干预措施: Optical Coherence Tomography (Device)
结局指标
主要结局
Specificity of 1300nm OCT in grading and staging UUT-UC
时间窗: up to 10 minutes
Only a single OCT measurement will be done during surgery. This measurement will take a maximum of 10 minutes, including preparation of the OCT device
Sensitivity of 1300nm OCT in grading and staging UUT-UC
时间窗: up to 10 minutes
Only a single OCT measurement will be done during surgery. This measurement will take a maximum of 10 minutes, including preparation of the OCT device
次要结局
未报告次要终点
研究者
M.T.J. Bus
M.D.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
