Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy

Inclusion Criteria: The patients should be indicated for a cystoscopic examination for suspected or verifiedpapillary bladder cancer and fulfill one or more of the following criteria:

• Patients with more than one initial bladder tumor confirmed on an outpatientcystoscopy.

• Patients having recurrence within 12 months confirmed on an outpatient cystoscopy

• Patients with more than one papillary lesion at recurrence independently of the timeof the recurrence confirmed on an outpatient cystoscopy

Exclusion Criteria:

• Patients with known tumors in the prostatic urethra or distal urethra

• Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resultingin marked amounts of blood in the urine, which may interfere with fluorescencecystoscopy. Where the bleed is light, the patient should not be excluded if in theinvestigator's opinion, rinsing during cystoscopy will alleviate the possibleinterference with fluorescence cystoscopy).

• Patient with porphyria.

• Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.

• Participation in other clinical studies with investigational drugs either concurrentlyor within the last 30 days.

• Pregnant or breast-feeding (all women of child-bearing potential must document anegative serum or urine pregnancy test at screening and use the contraceptive pill orintrauterine device (IUD) during the treatments and for at least one monththereafter).

• Patients who have received BCG or chemotherapy within three months prior to theinitial cystoscopy/TURB, except for a single dose of chemotherapy for prevention ofseeding after resection.

• Conditions associated with a risk of poor protocol compliance.