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
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
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.
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study within 1 year.
DISEASE CHARACTERISTICS:
Indication for cystoscopy for suspected or confirmed bladder cancer
Meets at least one of the following criteria:
No positive cytology obtained in the last 4 weeks
No prior G3 tumor with one set of positive random biopsies
No porphyria
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
More than 3 months since prior chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other