Unique ID issued by UMIN | UMIN000034165 |
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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 |
Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Japan |
Prostate cancer
Urology |
Malignancy
NO
To evaluate efficacy and safety of MRI/US fusion targeted biopsy using the BioJet system for accurate prostate cancer diagnosis
Safety,Efficacy
Cancer detection rate, target biopsies for each cancer-suspicious lesion would be performed using the BioJet system.
Evaluation of safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Diagnosis
Device,equipment |
Biojet system
Not applicable |
Not applicable |
Male
・Serum PSA level: 4.0-20.0ng/ml
・Significant cancer was suspected by MRI
・To obtain informed consent
・Anal stenosis
・Diabetes
・Infection nest in perineum site
・Clear hypoechoic area was detected by US on cancer suspecting region
400
1st name | Shin |
Middle name | |
Last name | Egawa |
Jikei University School of Medicine
Department of Urology
1058461
3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, JAPAN
03-3433-1111
s-egpro@jikei.ac.jp
1st name | Hiroshi |
Middle name | |
Last name | Sasaki |
Jikei University School of Medicine
Department of Urology
1058461
3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, JAPAN
03-3433-1111
hs06@jikei.ac.jp
Jikei University School of Medicine
Jikei University School of Medicine
Self funding
Jikei University IRB
3-25-8, Nishishinbashi, Minato-ku, Tokyo
03-3433-1111
rinri@jikei.ac.jp
NO
2018 | Year | 09 | Month | 17 | Day |
Unpublished
Completed
2017 | Year | 05 | Month | 16 | Day |
2017 | Year | 05 | Month | 16 | Day |
2018 | Year | 09 | Month | 10 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2018 | Year | 09 | Month | 15 | Day |
2023 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038948
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