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

Phase 3

Completed

• Conditions: Bladder Cancer
• Interventions: Other: Standard white light cystoscopy; Drug: Hexvix

• Registration Number: NCT00412971
• Lead Sponsor: Photocure

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 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.

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 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

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2013-08
• Results First Submitted: 2013-08-05
• Results First Submitted QC: 2013-08-05
• Last Update Submitted: 2013-08-05
• Results First Posted: 2013-10-11
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White light	Standard white light cystoscopy	Standard White light cystoscopy
Hexvix cystoscopy group	Hexvix	-

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.	1 year	To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.	At day 0
False Positive Detection Rate Patient Level	12 months

Trial Locations

Locations (2)

Odense University Hospital; 🇩🇰 Odense, Denmark

Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark