A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted
 Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with
 suspicion of non-invasive bladder cancer.

 The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix
 assisted TURB compared to standard white light TURB.
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted
 Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with
 suspicion of non-invasive bladder cancer.

 Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen
 is according to standard clinical practice in Denmark.

 Recurrence of non-invasive bladder cancer is frequent, and this study is designed to
 investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard
 TURB
Inclusion Criteria:

 -  Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral
 resection of the bladder

 -  Above 18 years

 -  Written informed consent obtained

 Exclusion Criteria:

 -  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).

 -  Conditions associated with a risk of poor protocol compliance.