Bladder Cancer Clinical Trial

Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

Summary

The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

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Full Description

A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone.

The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

No safety data was collected.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are eligible to be included in this study.

Exclusion Criteria:

Patient died during clinical study PC B305/04

Study is for people with:

Bladder Cancer

Estimated Enrollment:

551

Study ID:

NCT01166230

Recruitment Status:

Completed

Sponsor:

Photocure

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There are 23 Locations for this study

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Stanford Cancer Center, Department of Urology
Stanford California, 94305, United States
V.A. Medical Center
Gainesville Florida, 32608, United States
University of Miami School of Medicine
Miami Florida, 33136, United States
South Florida Clinical Research Center, Inc.
Pembroke Pines Florida, 33028, United States
The Emory Clinic, Dept of Urology
Atlanta Georgia, 30322, United States
Boston University School of Medicine
Boston Massachusetts, 02118, United States
Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Mount Sinai Medical Center, Department of Urology
New York New York, 10029, United States
URMC
Rochester New York, 14642, United States
Thomas Jefferson Medical College, Department of Neurology
Philadelphia Pennsylvania, 19107, United States
Vanderbilt University Medical Center, Department of Urologic Surgery
Nashville Tennessee, 37232, United States
Baylor College of Medicine, Scott Department of Urology
Houston Texas, 77030, United States
The University of Texas MD Anderson cancer center
Houston Texas, 77030, United States
AKH, Klinik für Urologie der Universität Wien
Wien , 1090, Austria
Kingston General Hospital
Kingston Ontario, K7L 2, Canada
CHUQ Hotel-Dieu de Quebec
Quebec , G1R 2, Canada
University Clinic of Giessen, Department of Urology
Giessen , 35392, Germany
Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik
München , 81377, Germany
Urologische Klinik München-Planegg
Planegg , 82152, Germany
Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie
Regensburg , 93053, Germany
Universitätsklinik Tuebingen, Universitätsklinik für Urologie
Tuebingen , 72076, Germany
Department of Urology, Academic Medical Center, University of Amsterdam
Amsterdam , 1105 , Netherlands
Department of Urology, UMC St. Radboud
Nijmegen , 6500 , Netherlands

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

551

Study ID:

NCT01166230

Recruitment Status:

Completed

Sponsor:


Photocure

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