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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.
- 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.
Allocation: Non-Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Diagnostic
hexyl 5-aminolevulinate, biopsy, cystoscopy
Jonsson Comprehensive Cancer Center, UCLA
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:34-0400
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Endoscopic examination, therapy or surgery of the urinary bladder.
Tumors or cancer of the URINARY BLADDER.
An enzyme of the transferase class that catalyzes condensation of the succinyl group from succinyl coenzyme A with glycine to form delta-aminolevulinate. It is a pyridoxyal phosphate protein and the reaction occurs in mitochondria as the first step of the heme biosynthetic pathway. The enzyme is a key regulatory enzyme in heme biosynthesis. In liver feedback is inhibited by heme. EC 184.108.40.206.
Conducting a biopsy procedure with the aid of a MEDICAL IMAGING modality.
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