Improved detection and treatment of bladder cancer using hexaminolevulinate imaging: a prospective, phase III multicenter study.

Abstract

PURPOSE:

We determined if improved tumor detection using hexaminolevulinate (HAL) fluorescence cystoscopy could lead to improved treatment in patients with bladder cancer.

MATERIALS AND METHODS:

A total of 146 patients with known or suspected bladder cancer were assessed in this open, comparative, within patient, controlled phase III study. Patients received intravesical HAL for 1 hour and were assessed with standard white light cystoscopy and blue light fluorescence cystoscopy. All lesions were mapped onto a bladder chart and biopsies were taken from suspicious areas for assessment by an independent pathologist. An independent urologist blinded to the detection method used recommended treatment plans based on biopsy results and medical history according to European Association of Urology bladder cancer guidelines. Any differences in recommended treatment plans arising from the 2 cystoscopy methods were recorded.

RESULTS:

HAL imaging improved overall tumor detection. Of all tumors 96% were detected with HAL imaging compared with 77% using standard cystoscopy. This difference was particularly noticeable for dysplasia (93% vs 48%), carcinoma in situ (95% vs 68%) and superficial papillary tumors (96% vs 85%). As a result of improved detection, additional postoperative procedures were recommended in 15 patients (10%) and more extensive treatment was done intraoperatively in a further 10. Overall 17% of patients received more appropriate treatment at the time of the study following blue light fluorescence cystoscopy, that is 22% or 1 of 5 if patients without tumors were excluded.

CONCLUSIONS:

HAL imaging is more effective than standard white light cystoscopy for detecting bladder tumors and lesions. This leads to improved treatment in a significant number of patients (p <0.0001).

• Authors: Dieter Jocham, Fred Witjes, Sigrid Wagner, Bram Zeylemaker, Jeroen van Moorselaar, Marc-Oliver Grimm, Rolf Muschter, Gralf Popken, Frank König, Ruth Knüchel, Karl-Heinz Kurth
• Journal: The Journal of urology (J Urol) Vol. 174 Issue 3 Pg. 862-6; discussion 866 (Sep 2005) ISSN: 0022-5347 [Print] United States
• PMID: 16093971 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Aminolevulinic Acid

Topics

• Administration, Intravesical
• Adult
• Aged
• Aged, 80 and over
• Aminolevulinic Acid
• Biopsy
• Cystoscopy (methods)
• Female
• Fluorescence
• Humans
• Lighting
• Male
• Middle Aged
• Neoplasm Staging
• Prospective Studies
• Sensitivity and Specificity
• Treatment Outcome
• Urinary Bladder (pathology)
• Urinary Bladder Neoplasms (diagnosis, pathology, surgery)
• Urothelium (pathology)
• Video Recording