Spots Global Cancer Trial Database for Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
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Trial Identification
Brief Title: Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
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
Study ID: NCT00233402
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford Cancer Center, Department of Urology, Stanford, California, United States
V.A. Medical Center, Gainesville, Florida, United States
University of Miami School of Medicine, Miami, Florida, United States
South Florida Clinical Research Center, Inc., Pembroke Pines, Florida, United States
The Emory Clinic, Dept of Urology, Atlanta, Georgia, United States
Boston University School of Medicine, Boston, Massachusetts, United States
St. Joseph Mercy Hospital- Ann Arbor, Ann Arbor, Michigan, United States
Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester, Rochester, Minnesota, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Mount Sinai Medical Center, Department of Urology, New York, New York, United States
URMC, Rochester, New York, United States
Urological Institute at Beachwood Cleveland Clinic, Beachwood, Ohio, 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
AKH, Klinik für Urologie der Universität Wien, Wien, , Austria
Kingston General Hospital, Kingston, Ontario, Canada
CHUQ Hotel-Dieu de Quebec, Quebec, , Canada
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, , Germany
Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, , Netherlands
Department of Urology, UMC St. Radboud, Nijmegen, , Netherlands
Contact Details
Name: H Barton Grossman
Affiliation: The University of Texas, MD Anderson Cancer Center, Department of Urology
Role: PRINCIPAL_INVESTIGATOR
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