A Phase 3 interventional study of hexaminolevulinate and biopsy in Bladder Cancer, sponsored by Photocure. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-23.
Sponsored by Photocure · Phase 3, Interventional, and Diagnostic
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.
OBJECTIVES:
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
Browse Urinary Bladder Neoplasms studies →Photocure is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Meets at least one of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
More than 3 months since prior chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Photocure