Bladder Cancer Clinical Trial
Official title:
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:
- 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.
PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study within 1 year.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Diagnostic
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