A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

Last updated: August 5, 2013
Sponsor: Photocure
Overall Status: Completed

Phase

3

Condition

Bladder Cancer

Urothelial Carcinoma

Urothelial Cancer

Treatment

N/A

Clinical Study ID

NCT00412971
PC B304/04
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with suspicion of non-invasive bladder cancer indicated for a transuretheralresection of the bladder

  • Above 18 years

  • Written informed consent obtained

Exclusion

Exclusion Criteria:

  • 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).

  • Conditions associated with a risk of poor protocol compliance.

Study Design

Total Participants: 233
Study Start date:
April 01, 2005
Estimated Completion Date:
October 31, 2008

Study Description

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

Connect with a study center

  • Frederiksberg Hospital

    Frederiksberg, 2000
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense,
    Denmark

    Site Not Available

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