A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer

Inclusion Criteria:

The patients should be indicated for a cystoscopic examination for suspected or verified
papillary bladder cancer and 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 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 resulting
in marked amounts of blood in the urine, which may interfere with fluorescence
cystoscopy. Where the bleed is light, the patient should not be excluded if in the
investigator's opinion, rinsing during cystoscopy will alleviate the possible
interference 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
concurrently or within the last 30 days.

- Pregnant or breast-feeding (all women of child-bearing potential must document a
negative serum or urine pregnancy test at screening and use the contraceptive pill or
intrauterine device (IUD) during the treatments and for at least one month
thereafter).

- Patients who have received BCG or chemotherapy within three months prior to the
initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of
seeding after resection.

- Conditions associated with a risk of poor protocol compliance.