UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023240 |
|---|---|
| Receipt number | R000026780 |
| Scientific Title | Real time MRI-TRUS fusion image-guided transperineal target biopsy for the detection of the significant prostate cancer with BioJet system |
| Date of disclosure of the study information | 2016/07/20 |
| Last modified on | 2019/11/04 13:18:07 |
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Basic information
Public title
Real time MRI-TRUS fusion image-guided transperineal target biopsy for the detection of the significant prostate cancer with BioJet system
Acronym
MRI-TRUS fusion image-guided biopsy for detection of the significant prostate cancer with BioJet system
Scientific Title
Real time MRI-TRUS fusion image-guided transperineal target biopsy for the detection of the significant prostate cancer with BioJet system
Scientific Title:Acronym
MRI-TRUS fusion image-guided biopsy for detection of the significant prostate cancer with BioJet system
Region
| Japan |
Condition
Condition
Prostate cacer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To report clinical results of manually controlled targeted biopsy with real-time multiparametric magnetic resonance image (mpMRI)-transrectal ultrasound (TRUS) fusion images for the diagnosis of prostate cancer using the BioJet system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target biopsies for each cancer-suspicious lesion and 12 systematic biopsies would be performed using the BioJet system. Pathological findings of targeted and systematic biopsies were analyzed.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Target biopsies for each cancer-suspicious lesion and 12 systematic biopsies would be performed using the BioJet system. Pathological findings of targeted and systematic biopsies were analyzed.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. The patients with PSA level greater than 4.0 ng/ml and less than 20 ng/ml were performed mpMRI prospectively.
2. Consecutive patients with suspected prostate cancer from multiparametric MRI were recruited prospectively.
Key exclusion criteria
The patients with PSA level greater than 20ng/ml.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Sunao |
| Middle name | |
| Last name | Shoji |
Organization
Tokai Univeristy Hachioji Hospital
Division name
Department of Urology
Zip code
192-0032
Address
1838 Ishikawa-machi, Hachioji, Tokyo, Japan, 192-0032
TEL
042-639-1111
sunashoj@mail.goo.ne.jp
Public contact
Name of contact person
| 1st name | Sunao |
| Middle name | |
| Last name | Shoji |
Organization
Tokai Univeristy Hachioji Hospital
Division name
Department of Urology
Zip code
192-0032
Address
1838 Ishikawa-machi, Hachioji, Tokyo, Japan, 192-0032
TEL
042-639-1111
Homepage URL
sunashoj@mail.goo.ne.jp
Sponsor or person
Institute
Department of Urology, Tokai University Hachioji Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokai Universty School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai Univeristy School of Medicine
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
sunashoj@mail.goo.ne.jp
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
東海大学医学部付属八王子病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 20 | Day |
Last modified on
| 2019 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026780
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
