UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011770 |
|---|---|
| Receipt number | R000006675 |
| 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 prostatectomy |
| Date of disclosure of the study information | 2013/09/14 |
| Last modified on | 2019/08/09 09:44:30 |
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Basic information
Public 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 prostatectomy
Acronym
Intraoperative photodynamic diagnosis of prostate cancer
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 prostatectomy
Scientific Title:Acronym
Intraoperative photodynamic diagnosis of prostate cancer
Region
| Japan |
Condition
Condition
Localized prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy 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 prostatectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy: The levels in images of the 5-ALA-induced fluorescence were compared with the pathological results.
Key secondary outcomes
Safety: The occurrence frequency and degree of adverse event were investigated through the procedures.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
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 was administrated orally (1.0g/50ml).
For fluorescence excitation a blue light source (D-Light AF System) was used. Under fluorescence light guidance outputted by light source apparatus and videocamera system (Endovision TELECAM SL/IPM-PPD System), fluorescence lesions were recorded and resected.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Patient who has localized prostate cancer indicated for prostatectomy (open surgery, laparoscopic surgery or robot-assisted surgery)
Key exclusion criteria
Patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity nad liver dysfunction.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Matsubara |
Organization
Hiroshima University
Division name
Department of Urology
Zip code
Address
1-2-3, kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5242
urology@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanao Kobayashi |
Organization
Hiroshima University
Division name
Department of Urology
Zip code
Address
1-2-3, kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5242
Homepage URL
urology@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Urology, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006675
