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

Phase 3

Completed

Conditions: Bladder Cancer

Interventions: Drug: Hexvix
Procedure: Standard white light cystoscopy

Registration Number: NCT00233402

Lead Sponsor: Photocure

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 789

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard White Light and Hexvix Fluorescence Cystoscopy	Hexvix	-
Standard White Light and Hexvix Fluorescence Cystoscopy	Standard white light cystoscopy	-
Standard White Light Cystoscopy	Standard white light cystoscopy	-

Primary Outcome Measures

Name	Time	Method
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
Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light	Day 0

Secondary Outcome Measures

Name	Time	Method
Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.	Day 0	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.
Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.	Day 0

Trial Locations

Locations (25): Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester
🇺🇸
Rochester, Minnesota, United States
Mount Sinai Medical Center, Department of Urology
🇺🇸
New York, New York, United States
University of Miami School of Medicine
🇺🇸
Miami, Florida, United States
St. Joseph Mercy Hospital- Ann Arbor
🇺🇸
Ann Arbor, Michigan, United States
Stanford Cancer Center, Department of Urology
🇺🇸
Stanford, California, United States
V.A. Medical Center
🇺🇸
Gainesville, Florida, United States
The Emory Clinic, Dept of Urology
🇺🇸
Atlanta, Georgia, United States
Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik
🇩🇪
München, Germany
Universitätsklinik Tuebingen, Universitätsklinik für Urologie
🇩🇪
Tuebingen, Germany
Department of Urology, Academic Medical Center, University of Amsterdam
🇳🇱
Amsterdam, Netherlands
Kingston General Hospital
🇨🇦
Kingston, Ontario, Canada
CHUQ Hotel-Dieu de Quebec
🇨🇦
Quebec, Canada
Department of Urology, UMC St. Radboud
🇳🇱
Nijmegen, Netherlands
Urological Institute at Beachwood Cleveland Clinic
🇺🇸
Beachwood, Ohio, United States
URMC
🇺🇸
Rochester, New York, United States
Thomas Jefferson Medical College, Department of Neurology
🇺🇸
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Department of Urologic Surgery
🇺🇸
Nashville, Tennessee, United States
Baylor College of Medicine, Scott Department of Urology
🇺🇸
Houston, Texas, United States
South Florida Clinical Research Center, Inc.
🇺🇸
Pembroke Pines, Florida, United States
Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
University Clinic of Giessen, Department of Urology
🇩🇪
Giessen, Germany
Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie
🇩🇪
Regensburg, Germany
Urologische Klinik München-Planegg
🇩🇪
Planegg, Germany
AKH, Klinik für Urologie der Universität Wien
🇦🇹
Wien, Austria
Boston University School of Medicine
🇺🇸
Boston, Massachusetts, United States