Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB



Status:Completed
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2013
Start Date:June 2010
End Date:December 2010

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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 Cystoscopy/Turb or White Light Cystoscopy/TURB


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.


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.

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
We found this trial at
13
sites
Rochester, New York 14642
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Boston University School of Medicine A leader in medical education and research, Boston University School...
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Boston, MA
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Atlanta, Georgia 30322
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Atlanta, GA
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Gainesville, Florida 32608
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Gainesville, FL
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Houston, TX
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Miami, FL
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Nashville, TN
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New York, NY
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Pembroke Pines, Florida 33028
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Pembroke Pines, FL
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Philadelphia, PA
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Rochester, MN
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Stanford, CA
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