Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
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.
Procedure: Standard white light cystoscopy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|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|
- Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Study Completion Date:||August 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: Standard White Light Cystoscopy||Procedure: Standard white light cystoscopy|
|Experimental: Standard White Light and Hexvix Fluorescence Cystoscopy||
Single Instillation, Transurethral Resection of the BladderProcedure: Standard white light cystoscopy
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.
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|Principal Investigator:||H Barton Grossman||The University of Texas, MD Anderson Cancer Center, Department of Urology|