IMPROVED DETECTION AND TREATMENT OF BLADDER CANCER USING HEXAMINOLEVULINATE IMAGING: A PROSPECTIVE, PHASE III MULTICENTER STUDY

ABSTRACTPurpose: 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 ...