Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy

Bladder Cancer Clinical Trial

Official title:

A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233402
• Other study ID #: PC B305/02
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2005
• Last updated: August 5, 2013
• Start date: January 2005
• Est. completion date: August 2008

Study information

• Verified date: August 2013
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesAustria: Federal Ministry for Health and WomenNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.

Description:

In superficial bladder cancer macroscopic tumors including non-invasive papillary tumors (Ta) in the bladder are relatively easy to visualize by cystoscopic examination under white light. However, dysplasia, carcinoma in situ (CIS) or small exophytic tumors are easily overlooked. These lesions are predictive of recurrence and progression of disease, and the identification of these lesions is a crucial factor for the prognosis of the patient. The present situation with 50-75% recurrence rate show the inadequacy of white light cystoscopy for detection and resection of the lesions.

A better detection of papillary bladder cancer and early detection of CIS lesions will provide the patient with a more complete TURB, a more optimal pharmacological treatment when needed, may reduce the need for follow up cystoscopies and hopefully result in a better prognosis for the patient.

The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer and to compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer.

Other known NCT identifiers

• NCT00209157

Recruitment information / eligibility

• Status: Completed
• Enrollment: 789
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The patients should be indicated for a cystoscopic examination for suspected or verified papillary bladder cancer and fulfill one or more of the following criteria:

• Patients with more than one initial bladder tumor confirmed on an outpatient cystoscopy.

• Patients having recurrence within 12 months confirmed on an outpatient cystoscopy

• Patients with more than one papillary lesion at recurrence independently of the time of the recurrence confirmed on an outpatient cystoscopy

Exclusion Criteria:

• Patients with known tumors in the prostatic urethra or distal urethra

• 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).

• Patients who have received BCG or chemotherapy within three months prior to the initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of seeding after resection.

• Conditions associated with a risk of poor protocol compliance.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Hexvix
Single Instillation, Transurethral Resection of the Bladder

Procedure:
• Standard white light cystoscopy

Locations

Country	Name	City	State
Austria	AKH, Klinik für Urologie der Universität Wien	Wien
Canada	Kingston General Hospital	Kingston	Ontario
Canada	CHUQ Hotel-Dieu de Quebec	Quebec
Germany	University Clinic of Giessen, Department of Urology	Giessen
Germany	Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik	München
Germany	Urologische Klinik München-Planegg	Planegg
Germany	Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie	Regensburg
Germany	Universitätsklinik Tuebingen, Universitätsklinik für Urologie	Tuebingen
Netherlands	Department of Urology, Academic Medical Center, University of Amsterdam	Amsterdam
Netherlands	Department of Urology, UMC St. Radboud	Nijmegen
United States	St. Joseph Mercy Hospital- Ann Arbor	Ann Arbor	Michigan
United States	The Emory Clinic, Dept of Urology	Atlanta	Georgia
United States	Urological Institute at Beachwood Cleveland Clinic	Beachwood	Ohio
United States	Boston University School of Medicine	Boston	Massachusetts
United States	V.A. Medical Center	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Baylor College of Medicine, Scott Department of Urology	Houston	Texas
United States	University of Miami School of Medicine	Miami	Florida
United States	Vanderbilt University Medical Center, Department of Urologic Surgery	Nashville	Tennessee
United States	Mount Sinai Medical Center, Department of Urology	New York	New York
United States	South Florida Clinical Research Center, Inc.	Pembroke Pines	Florida
United States	Thomas Jefferson Medical College, Department of Neurology	Philadelphia	Pennsylvania
United States	URMC	Rochester	New York
United States	Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester	Rochester	Minnesota
United States	Stanford Cancer Center, Department of Urology	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Photocure

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light		Day 0	No
Primary	Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.		9 months	No
Secondary	Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.	The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive).; The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately.	Day 0	No
Secondary	Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.		Day 0	No