Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Compare blue light fluorescent cystoscopy with reconstituted hexyl 5-aminolevulinate (Hexvix®) vs white light cystoscopy for the detection of carcinoma in situ (CIS) in patients with bladder cancer. Compare the positive and false detection rates of histologically confirmed non-CIS lesions and dysplasia by these modalities in these patients. Compare the false detection rate of histologically confirmed CIS lesions by these modalities in these patients. Compare the number of tumor lesions and dysplasia detected by these modalities in these patients. Compare management of patients after evaluation with these modalities. Determine the safety of reconstituted hexyl 5-aminolevulinate (Hexvix®) in these patients. OUTLINE: This is an open-label, multicenter study. Patients undergo bladder catheterization and instillation of reconstituted hexyl 5-aminolevulinate (Hexvix®). After 60 minutes the bladder is evacuated, and the patient undergoes cystoscopic examination of the bladder by white light and then blue light fluorescence. Biopsies are taken of all suspicious areas seen under white and/or blue light modalities, and one normal-appearing area seen under both light modalities, and papillary lesions are resected. Patients are followed at 7 days after procedure. PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study within 1 year.

Official Title
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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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: hexaminolevulinate
* Procedure: biopsy
* Procedure: cystoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hexaminolevulinate|nan|
|Procedure: biopsy|nan|
|Procedure: cystoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, recurrent bladder cancer, stage 0 bladder cancer