Bladder Cancer Clinical Trial
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
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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