Improved detection and treatment of bladder cancer using hexaminolevulinate imaging: a prospective, phase III multicenter study.
OBJECTIVE
We determined if improved tumor detection using hexaminolevulinate (HAL) fluorescence cystoscopy could lead to improved treatment in patients with bladder cancer.


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).
Jocham
Dieter
D
Department of Urology, University of Schleswig-Holstein, Lübeck, Germany.
Witjes
Fred
F
Wagner
Sigrid
S
Zeylemaker
Bram
B
van Moorselaar
Jeroen
J
Grimm
Marc-Oliver
MO
Muschter
Rolf
R
Popken
Gralf
G
König
Frank
F
Knüchel
Ruth
R
Kurth
Karl-Heinz
KH
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid; D001706:Biopsy; D003558:Cystoscopy / Q000379:methods*; D005260:Female; D005453:Fluorescence; D006801:Humans; D008029:Lighting; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000473:pathology; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D019459:Urothelium / Q000473:pathology; D014741:Video Recording
D000622:Aminolevulinic Acid