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

Bladder Cancer Clinical Trial

Official title:

A Randomized, Comparative Phase III, 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412971
• Other study ID #: PC B304/04
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2006
• Last updated: August 5, 2013
• Start date: April 2005
• Est. completion date: October 2008

Study information

• Verified date: August 2013
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Hexvix
Single installation, TURB

Other:
• Standard white light cystoscopy

Locations

Country	Name	City	State
Denmark	Frederiksberg Hospital	Frederiksberg
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Photocure

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With Histologically Confirmed Recurrence Within One 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.	1 year	No
Secondary	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	No
Secondary	False Positive Detection Rate Patient Level		12 months	No