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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
To compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer.
9 months
No
H Barton Grossman
Principal Investigator
The University of Texas, MD Anderson Cancer Center, Department of Urology
United States: Food and Drug Administration
PC B305/02
NCT00233402
January 2005
August 2008
Name | Location |
---|---|
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Boston University School of Medicine | Boston, Massachusetts 02118 |
University of Miami School of Medicine | Miami, Florida 33136 |
Stanford Cancer Center, Department of Urology | Stanford, California 94305-5820 |
V.A. Medical Center | Gainesville, Florida 32608 |
South Florida Clinical Research Center, Inc. | Pembroke Pines, Florida 33028 |
The Emory Clinic, Dept of Urology | Atlanta, Georgia 30322 |
St. Joseph Mercy Hospital- Ann Arbor | Ann Arbor, Michigan 48106 |
Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester | Rochester, Minnesota 55905 |
Mount Sinai Medical Center, Department of Urology | New York, New York 10029-6574 |
URMC | Rochester, New York 14642 |
Urological Institute at Beachwood Cleveland Clinic | Beachwood, Ohio 44120 |
Thomas Jefferson Medical College, Department of Neurology | Philadelphia, Pennsylvania 19107 |
Vanderbilt University Medical Center, Department of Urologic Surgery | Nashville, Tennessee 37232-2765 |
Baylor College of Medicine, Scott Department of Urology | Houston, Texas 77030-2726 |