Unique ID issued by UMIN | UMIN000003251 |
---|---|
Receipt number | R000003934 |
Scientific Title | Intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of radical prostatectomy |
Date of disclosure of the study information | 2010/02/24 |
Last modified on | 2014/08/07 16:16:39 |
Intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of radical prostatectomy
Intraoperative photodynamic diagnosis of prostate cancer
Intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of radical prostatectomy
Intraoperative photodynamic diagnosis of prostate cancer
Japan |
Localized prostate cancer
Urology |
Malignancy
NO
To investigate the value of the intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of radical prostatectomy
Safety
Confirmatory
Pragmatic
Phase I,II
Diagnostic accuracy: The levels in images of the 5-ALA-induced fluorescence were compared with the pathological results.
Safety:The occurrence frequency and degree of adverse event were
investigated through the procedures.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Diagnosis
Medicine | Device,equipment | Maneuver |
Three to four hours prior to operation 1.0g 5-aminolevulinic acid (5-ALA) (unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50ml of 5% glucose solution and 8.4% sodium hydrogen carbonate (NaHCO3) solution was administrated orally (1.0g/50ml).
For fluorescence excitation a blue light source (D-LIGHT System) was used.
Under fluorescence light guidance outputted by light source apparatus (D-Light AF System) and videocamera system (Endovision TELECAM SL/IPM-PPD System), fluorescent lesions were recorded and resected.
20 | years-old | <= |
80 | years-old | > |
Male
Patient who has localized prostate cancer indicated for radical prostatectomy (open surgery or laparoscopic surgery)
Patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction
330
1st name | |
Middle name | |
Last name | Taro Shuin |
Kochi Medical School
Department of Urology, Kochi Medical School
Kohasu, Oko, Nankoku, Kochi, Japan
088-880-2402
shuint@kochi-u.ac.jp
1st name | |
Middle name | |
Last name | Keiji Inoue |
Kochi Medical School
Department of Urology, Kochi Medical School
Kohasu, Oko, Nankoku, Kochi, Japan
088-880-2402
keiji@kochi-u.ac.jp
Department of Urology, Kochi Medical School
None
Self funding
NO
高知大学医学部附属病院
2010 | Year | 02 | Month | 24 | Day |
Unpublished
Completed
2007 | Year | 01 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2020 | Year | 03 | Month | 01 | Day |
2020 | Year | 03 | Month | 01 | Day |
2020 | Year | 03 | Month | 01 | Day |
2020 | Year | 03 | Month | 01 | Day |
2010 | Year | 02 | Month | 24 | Day |
2014 | Year | 08 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003934
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |