Status:
COMPLETED
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
Lead Sponsor:
Photocure
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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, dys...
Eligibility Criteria
Inclusion
- The patients should be indicated for a cystoscopic examination for suspected or verified papillary bladder cancer and fulfill one or more of the following criteria:
- Patients with more than one initial bladder tumor confirmed on an outpatient cystoscopy.
- Patients having recurrence within 12 months confirmed on an outpatient cystoscopy
- Patients with more than one papillary lesion at recurrence independently of the time of the recurrence confirmed on an outpatient cystoscopy
Exclusion
- Patients with known tumors in the prostatic urethra or distal urethra
- Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
- Patient with porphyria.
- Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
- Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
- Patients who have received BCG or chemotherapy within three months prior to the initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of seeding after resection.
- Conditions associated with a risk of poor protocol compliance.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
789 Patients enrolled
Trial Details
Trial ID
NCT00233402
Start Date
January 1 2005
End Date
August 1 2008
Last Update
October 11 2013
Active Locations (25)
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1
Stanford Cancer Center, Department of Urology
Stanford, California, United States, 94305-5820
2
V.A. Medical Center
Gainesville, Florida, United States, 32608
3
University of Miami School of Medicine
Miami, Florida, United States, 33136
4
South Florida Clinical Research Center, Inc.
Pembroke Pines, Florida, United States, 33028