An Open, Comparative, Within Patient, Controlled Phase III, Multicenter Study Of HEXVIX Fluorescence Cystoscopy And White Light Cystoscopy In the Detection Of Carcinoma In Situ In Patients With Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Diagnostic procedures such as cystoscopy may improve the ability to detect cancer and to determine the extent of disease.
PURPOSE: Diagnostic trial to compare the effectiveness of cystoscopy using hexyl 5-aminolevulinate and two light sources in detecting carcinoma in situ in patients who have bladder cancer.
详细描述
OBJECTIVES:
- Compare blue light fluorescent cystoscopy with reconstituted hexyl 5-aminolevulinate (Hexvix®) vs white light cystoscopy for the detection of carcinoma in situ (CIS) in patients with bladder cancer.
- Compare the positive and false detection rates of histologically confirmed non-CIS lesions and dysplasia by these modalities in these patients.
- Compare the false detection rate of histologically confirmed CIS lesions by these modalities in these patients.
- Compare the number of tumor lesions and dysplasia detected by these modalities in these patients.
- Compare management of patients after evaluation with these modalities.
- Determine the safety of reconstituted hexyl 5-aminolevulinate (Hexvix®) in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients undergo bladder catheterization and instillation of reconstituted hexyl 5-aminolevulinate (Hexvix®). After 60 minutes the bladder is evacuated, and the patient undergoes cystoscopic examination of the bladder by white light and then blue light fluorescence. Biopsies are taken of all suspicious areas seen under white and/or blue light modalities, and one normal-appearing area seen under both light modalities, and papillary lesions are resected.
Patients are followed at 7 days after procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Indication for cystoscopy for suspected or confirmed bladder cancer
- •Meets at least one of the following criteria:
- •Multiple bladder lesions
- •Bladder lesion greater than 3 cm
- •Bladder tumor of at least stage T1
- •Grade 2 or 3 bladder tumor
- •Recurrent bladder cancer
- •No positive cytology obtained in the last 4 weeks
- •No prior G3 tumor with one set of positive random biopsies
- •No porphyria
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •No gross hematuria
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after study
- •No known allergy to reconstituted hexyl 5-aminolevulinate or a similar compound
- •No concurrent condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 3 months since prior BCG
- •Chemotherapy
- •More than 3 months since prior chemotherapy
- •Single prior dose of chemotherapy for prevention of seeding after resection allowed
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 30 days since prior participation in another clinical trial
- •No concurrent participation in another clinical trial
排除标准
- 未提供