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Title: Hexyl Aminolevulinate Fluorescence Improves Detection of Carcinoma In Situ of the Bladder: Presented at AUA
 "Hexyl Aminolevulinate Fluorescence Improves Detection of Carcinoma In Situ of the Bladder: Presented at AUA"


By Jill Stein CHICAGO, IL -- April 29, 2003 -- Hexyl aminolevulinate (HAL) fluorescence is more effective than standard cystoscopy for detecting carcinoma in situ (CIS) of the bladder, researchers said here April 28th at the 2003 Annual Meeting of the American Urological Association. Dr. Michael Marberger, from University of Vienna, in Austria, presented the results of a multicenter European study that evaluated fluorescence cystoscopy and standard light cystoscopy using HAL for the detection of CIS of the bladder in 211 high-risk patients. Carcinoma in situ is associated with a high risk of tumor progression due to its aggressive, unpredictable nature," Dr. Marberger pointed out. Carcinoma in situ, a flat lesion, is difficult to identify at standard cystoscopy and can be missed. Urinary cytology has a high sensitivity and specificity but is highly dependent on the training and expertise of the investigator, he continued. Fluorescence cystoscopy improves the detection of transitional cell carcinoma by 20% to 30%. While early clinical experience suggested that HAL fluorescence cystoscopy had a better detection rate for CIS than standard cystoscopy, this observation had not been verified in large multicenter studies. Dr. Marberger's trial included patients with multiple bladder tumors or suspicious lesions, a tumor larger than 3 cm in diameter, positive urine cytology, history of transitional cell carcinoma or pTa G2/G3 tumor, or a recurrent bladder tumor at follow-up cystoscopy. All suspicious lesions were mapped, biopsied, or resected by transurethral resection and assessed by a reference pathologist. The study found that HAL detected 28% more CIS patients and 67% more CIS lesions than standard cystoscopy. The per-patient sensitivity rates for detecting CIS were 96% with HAL cystoscopy and 73% with standard cystoscopy. The HAL technique detected an additional 10% pTA lesions. In patients with papillary pTa lesions without CIS, HAL cystoscopy identified an additional 11% of lesions. The false detection rate was low and similar for both HAL and standard cystoscopy (13% and 10%). The safety profile of HAL cystoscopy was excellent, said Dr. Marberger. The study was funded by the Hexvix PCB301/01 Study Group. [Study title: Hexyl Aminolevulinate (HAL) Fluorescence Versus Standard Cystoscopy for Detecting Carcinoma In Situ (CIS) of the Bladder. Abstract 1006]






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