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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 28^th 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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