Feasibility of Confocal Laser Endomicroscopy in Bladder Cancer Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Confocal laser endomicroscopy characteristics of urothelium of the lower urinary tract
研究概览
简要总结
Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging technique, that can be used combined with endo-urological procedures, seems promising to improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic applied confocal laser endomicroscopy (CLE) still has to be defined.
Objective: To directly correlate CLE images with histopathology, and identify and define CLE characteristics of normal urothelium, benign bladder urothelium, and bladder tumors (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract.
Primary objective: to develop descriptive image interpretation criteria and a classification of CLE images of bladder tissue through a review of prospectively obtained CLE videos from bladder tissue correlated with histopathology.
Secondary objectives:
- Assessing procedure related adverse events of CLE
- Assessing technical feasibility of CLE
- To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign, low-grade or high-grade and CIS)
详细描述
This is a prospective, multicenter, observational study; the investigators will establish sensitivity and specificity of CLE ex vivo and in vivo, in the diagnosis of bladder carcinoma.
Eligible patients are diagnosed with a bladder tumor at the outpatient clinic and scheduled for transurethral resection of bladder tumor (TURB). In total the investigators want to include 60 patients. Yearly approximately 70 patients are diagnosed with primary and recurrent bladder carcinoma in the Academic Medical Center (AMC) and will undergo TURB.
Their Urologist will inform patients diagnosed with a bladder tumor who will be scheduled for treatment by means of TURB about the study. Information about the study will be provided both orally and in written form.
CLE images are recorded using a probe-based system (Cellvizio 100 series, Mauna Kea Technologies, Paris, France). The probe (Cystoflex UHD-R, Mauna Kea Technologies, Paris, France) has an outer diameter of 2.8 mm, a field of view of 240 µm and has a resolution of 1 µm. Images are collected at a scan rate of 12 frames per second. Using the Cellvizio Viewer system, the investigators can observe mucosal microarchitecture with an increased field of view through mosaic post processing. This system also enables virtual staining of mucosal structures to further enhance tissue contrast.
A fluorescent contrast agent is needed to obtain CLE images. Fluorescein (fluoresceinedisodium, Fresenius Kabi, Zeist, Netherlands), a non-toxic and commonly used fluorescent dye will be administered intravesical (300-400 mL 0.1% fluorescein diluted in saline) and left indwelling for 5 minutes to stain the extracellular matrix.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 >18 years old
- •Bladder tumor(s)
- •Candidate for TURB
- •Signed informed consent
排除标准
- •Patients <18 years old
- •Patients with known allergy for fluorescein
- •Possible pregnancy or lactating women
- •No signed informed consent
结局指标
主要结局
Confocal laser endomicroscopy characteristics of urothelium of the lower urinary tract
时间窗: 1.5 years
Qualitatively correlating CLE images to histopathology to define CLE characteristics
次要结局
未报告次要终点
研究者
Prof.dr. J.J.M.C.H. de la Rosette
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)