Bladder Cancer Clinical Trial
Official title:
An Open, Comparative, Within Patient, Controlled Phase III, Multicenter Study Of HEXVIX Fluorescence Cystoscopy And White Light Cystoscopy In the Detection Of Carcinoma In Situ In Patients With Bladder Cancer
Verified date | October 2013 |
Source | Photocure |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Diagnostic procedures such as cystoscopy may improve the ability to detect cancer
and to determine the extent of disease.
PURPOSE: Diagnostic trial to compare the effectiveness of cystoscopy using hexyl
5-aminolevulinate and two light sources in detecting carcinoma in situ in patients who have
bladder cancer.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | May 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Indication for cystoscopy for suspected or confirmed bladder cancer - Meets at least one of the following criteria: - Multiple bladder lesions - Bladder lesion greater than 3 cm - Bladder tumor of at least stage T1 - Grade 2 or 3 bladder tumor - Recurrent bladder cancer - No positive cytology obtained in the last 4 weeks - No prior G3 tumor with one set of positive random biopsies - No porphyria PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - No gross hematuria Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study - No known allergy to reconstituted hexyl 5-aminolevulinate or a similar compound - No concurrent condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - More than 3 months since prior BCG Chemotherapy - More than 3 months since prior chemotherapy - Single prior dose of chemotherapy for prevention of seeding after resection allowed Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - More than 30 days since prior participation in another clinical trial - No concurrent participation in another clinical trial |
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Photocure | National Cancer Institute (NCI) |
United States,
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