The Utility of a Flexible Fluorescence-Cystoscope with a Twin Mode Monitor for the 5-Aminolevulinic Acid-Mediated Photodynamic Diagnosis of Bladder Cancer.
OBJECTIVE
To evaluate the diagnostic value of a new photodynamic diagnosis (PDD) system using 5-aminolevulinic acid (ALA) for the diagnosis of bladder tumors. To validate whether false-positive findings caused by tangent effects in PDD can be resolved, we compared diagnostic accuracies between the new PDD system and a conventional PDD system.


METHODS
Among 30 transurethral bladder biopsies, 15 cases received ALA-PDD using rigid fluorescence cystoscopy (conventional PDD system), and flexible fluorescence cystoscopy with a twin mode monitor (new PDD system) was used in a separate set of 15 cases. To evaluated the usefulness of ALA-PDD, diagnostic accuracies were retrospectively compared between the conventional PDD system and the new PDD system.


RESULTS
Of 207 specimens from 30 cases, we obtained 110 specimens using the conventional PDD system and 97 specimens using the new PDD system. Of these samples, we selected 30 distal bladder specimens each from both the conventional PDD system and the new PDD system. The overall sensitivity, specificity and false-positive rate for the new PDD system were 100%, 82.6%, and 17.4%, respectively. Those of the conventional PDD system were 83.3%, 66.2% and 33.8%, respectively. The overall false-positive rate of the new PDD system improved to 16.4% when compared with the conventional PDD system. Furthermore, the false-positive rate of the new PDD system in distal bladder samples improved to 11.8%. The overall AUC of the new PDD system was significantly greater compared with that of the conventional PDD system (P<0.05). We obtained similar significant results in the distal bladder samples (P<0.05). All procedures were well tolerated by all patients without any severe adverse events.


CONCLUSIONS
Flexible cystoscopy had a significantly higher specificity and improved incidence of tangent effects when compared with conventional methods. This preliminary study suggests that the new PDD system using 5-aminolevulinic acid may be more useful than the conventional PDD system.
Department of Urology, Kochi Medical School, Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
Hideo
H
Fukuhara
R&D Center, HOYA Corporation, 3-3-1 Musashino, Akishima-shi, Tokyo 196-8510, Japan.
Mitsuhiro
M
Kureishi
SBI Pharmaceuticals Company, Ltd., 1-6-1 Roppongi, Minato-ku, Tokyo 106-6020, Japan.
Takeo
T
Khoda
SBI Pharmaceuticals Company, Ltd., 1-6-1 Roppongi, Minato-ku, Tokyo 106-6020, Japan.
Katsushi
K
Inoue
SBI Pharmaceuticals Company, Ltd., 1-6-1 Roppongi, Minato-ku, Tokyo 106-6020, Japan.
Tohru
T
Tanaka
R&D Center, HOYA Corporation, 3-3-1 Musashino, Akishima-shi, Tokyo 196-8510, Japan.
Kohei
K
Iketani
R&D Center, HOYA Corporation, 3-3-1 Musashino, Akishima-shi, Tokyo 196-8510, Japan.
Masahiro
M
Orita
Department of Urology, Kochi Medical School, Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
Keiji
K
Inoue
Department of Urology, Kochi Medical School, Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
Taro
T
Shuin
D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage*; D020684:Cystoscopes / Q000009:adverse effects; D003558:Cystoscopy / Q000009:adverse effects / Q000379:methods*; D005189:False Positive Reactions; D005260:Female; D005453:Fluorescence; D006801:Humans; D008297:Male; D008875:Middle Aged; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D001743:Urinary Bladder / Q000473:pathology*; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000473:pathology
D017319:Photosensitizing Agents; D000622:Aminolevulinic Acid