UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034165 |
|---|---|
| Receipt number | R000038948 |
| Scientific Title | Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound |
| Date of disclosure of the study information | 2018/09/17 |
| Last modified on | 2023/03/19 13:47:58 |
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Basic information
Public title
Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Acronym
Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Scientific Title
Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Scientific Title:Acronym
Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of MRI/US fusion targeted biopsy using the BioJet system for accurate prostate cancer diagnosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer detection rate, target biopsies for each cancer-suspicious lesion would be performed using the BioJet system.
Key secondary outcomes
Evaluation of safety
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
| Device,equipment |
Interventions/Control_1
Biojet system
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
･Serum PSA level: 4.0-20.0ng/ml
･Significant cancer was suspected by MRI
･To obtain informed consent
Key exclusion criteria
･Anal stenosis
･Diabetes
･Infection nest in perineum site
･Clear hypoechoic area was detected by US on cancer suspecting region
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Egawa |
Organization
Jikei University School of Medicine
Division name
Department of Urology
Zip code
1058461
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, JAPAN
TEL
03-3433-1111
s-egpro@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sasaki |
Organization
Jikei University School of Medicine
Division name
Department of Urology
Zip code
1058461
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, JAPAN
TEL
03-3433-1111
Homepage URL
hs06@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
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
Jikei University IRB
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 17 | 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
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
