UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027196 |
|---|---|
| Receipt number | R000031146 |
| Scientific Title | A feasibility study of photoacoustic imaging system for detection of prostate cancer |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2017/04/30 08:07:33 |
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Basic information
Public title
A feasibility study of photoacoustic imaging system for detection of prostate cancer
Acronym
Photoacoustic imaging for detection of prostate cancer
Scientific Title
A feasibility study of photoacoustic imaging system for detection of prostate cancer
Scientific Title:Acronym
Photoacoustic imaging for detection of prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the photoacoustic imaging findings of prostate cancer and to study the feasibility in prostate cancer imaging.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive predictive value of photoacoustic imaging-guided prostate biopsy in detecting prostate cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Under local anesthesia, photoacoustic images of the prostate are taken by using transrectal probe for photoacoustic images. Patterns of photoacoustic images and their location are reviewed and targetted biopsy for cancerous areas are performed.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Over 20-year old
2. Having written informed consent
3. Serum PSA greater than 4.0 ng/ml
4. Prostate biopsy is scheduled
Key exclusion criteria
Patients who have no informed consent, or those who are judged as inadequate.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | AKIO HORIGUCHI |
Organization
National Defense Medical College
Division name
Department of Urology
Zip code
Address
Namiki 3-2, Tokorozawa, Saitama 359-8513, Japan
TEL
04-2995-1211
impreza@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MIYA ISHIHARA |
Organization
National Defense Medical College
Division name
Department of Medical Engineering
Zip code
Address
Namiki 3-2, Tokorozawa, Saitama 359-8513, Japan
TEL
04-2995-1211
Homepage URL
kobako@ndmc.ac.jp
Sponsor or person
Institute
Ministry of Defense
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | 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
Date of protocol fixation
| 2017 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 30 | Day |
Last modified on
| 2017 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031146
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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