Trial Information

Summary: A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection of Papillary Bladder Cancer and Early Recurrence rate in Patients with Bladder Cancer.

This is a study comparing a new method (Hexvix cystoscopy) for detecting bladder cancer to the method currently being used (standard cystoscopy) and see if this new method will lead to fewer early recurrences in patients with bladder cancer.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

Male or female, aged 18 years or above and must fulfill one or more of the following criteria:
- Patients with more than one initial bladder tumor confirmed on an outpatient cystoscopy.
- Patients having recurrence within 12 months confirmed on an outpatient cystoscopy.
- Patients with more than one papillary lesion at recurrence independently of the time of the time of the recurrence confirmed on an outpatient cystoscopy.

For all patients screened:
- Patients with known tumors in the prostatic urethra or distal urethra.
- Gross hematuria (defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy.
- Patient with porphyria.
- Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
- Participation in other clinical studies within the last 30 days.
- Patients who are pregnant or breast-feeding.
- Patients who have received BCG or chemotherapy within three months prior to initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of seeding after resection.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.