CLINICAL TRIAL SUMMARY

MDACC Study No:2004-0495 (clinicaltrials.gov NCT No: NCT00209157)
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
Principal Investigator:Barton Grossman
Treatment Agent:Hexvix
Study Status:Terminated
Study Description:The goal of this clinical research study is to see if the new drug Hexyl
5-aminolevulinate can help doctors to find bladder cancers more easily, which
may allow them to give a more appropriate treatment. Researchers will study
whether this way to find bladder cancer will lower the chances of the cancer
coming back 3, 6, and 9 months after the tumor has been removed. The safety of
this new drug will also be studied.

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Disease Group:Bladder
Phase of Study:Phase III
Treatment Agents:Hexvix
Treatment Location:Independent Multicenter Arrangements
Estimated Length of Stay in Houston:Patients will stay 23 hours or less at the time of cystoscopy. Some patients
may be discharged the same day.
Supported By:N/A
Return Visit:Patients will have a screening evaluation followed by cystoscopy/TURB and 3
follow up cystoscopic examinations three, six and nine months after the initial
cystoscopy/TURB.
Home Care:None


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Physician Name:Barton Grossman
Dept:Urology
For Clinical Trial Enrollment:713-792-3250
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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