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Sponsored by: |
PhotoCure |
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Information provided by: | PhotoCure |
ClinicalTrials.gov Identifier: | NCT00233402 |
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.
Condition | Intervention | Phase |
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Bladder Cancer |
Drug: Hexvix |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 789 |
Study Start Date: | January 2005 |
Study Completion Date: | August 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Standard White Light Cystoscopy
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Drug: Hexvix
Single Instillation, Transurethral Resection of the Bladder
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2: Experimental
Standard White Light and Hexvix Fluorescence Cystoscopy
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Drug: Hexvix
Single Instillation, Transurethral Resection of the Bladder
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria:
Principal Investigator: | H Barton Grossman | The University of Texas, MD Anderson Cancer Center, Department of Urology |
Responsible Party: | Photocure ASA ( Mona Welschof ) |
Study ID Numbers: | PC B305/02 |
Study First Received: | October 4, 2005 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00233402 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Ministry for Health and Women; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Bladder Cancer Hexvix Fluorescence Cystoscopy |
Urinary Tract Neoplasm Cystocele Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms |
Urogenital Neoplasms Bladder Neoplasm Urologic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms |