Status:
COMPLETED
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
Lead Sponsor:
Photocure
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 no...
Detailed 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 no...
Eligibility Criteria
Inclusion
- Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder
- Above 18 years
- Written informed consent obtained
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00412971
Start Date
April 1 2005
End Date
October 1 2008
Last Update
October 11 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
2
Odense University Hospital
Odense, Denmark