Bladder Cancer Clinical Trial
Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Los Angeles California, 90095, United States
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