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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000027196
Receipt No. 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

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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
Email 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
Email kobako@ndmc.ac.jp

Sponsor
Institute Ministry of Defense
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031146

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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