View Clinical Trial (Medical Research Study)

An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study pc b305/04, to Assess a Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cyst

---

Conditions:		Bladder Cancer
Purpose:		The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.
Study Summary:		A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone. The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.
Criteria:		Inclusion Criteria: - Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are eligible to be included in this study. Exclusion Criteria: - Patient died during clinical study PC B305/04
NCT ID:		NCT01166230
Primary Contact:		Principal Investigator Herbert Barton Grossman, MD The University of Texas, MD Anderson Cancer Center
Backup Contact:		N/A
Location Contact:		Houston, Texas 77030 United States Joy Banerjee, CRC Phone: 713-798-4479 Email: JBanerjee@www.urol.bcm.tmc.edu Site Status: Not yet recruiting

---

---