UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053859 |
|---|---|
| Receipt number | R000061474 |
| Scientific Title | A single-center prospective study on the effectiveness of urethral MRI imaging in prostate cancer radiotherapy treatment. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/09/04 09:08:18 |
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Basic information
Public title
A single-center prospective study on the effectiveness of urethral MRI imaging in prostate cancer radiotherapy treatment.
Acronym
Urethral MRI trial
Scientific Title
A single-center prospective study on the effectiveness of urethral MRI imaging in prostate cancer radiotherapy treatment.
Scientific Title:Acronym
Urethral MRI trial
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility of using urethral MRI imaging with a condom-type urinary catheter in patients undergoing radiation therapy for prostate cancer to accurately locate the urethra, which is necessary for prostate cancer radiation treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the feasibility of urethral MRI imaging using a condom-type urinary catheter for accurate localization of the urethra.
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
MRI imaging with a condom-type urinary catheter
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
Patients undergoing radiation therapy for prostate cancer.
Key exclusion criteria
NA
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Ishiyama |
Organization
Kitasato university
Division name
Radiation oncology
Zip code
2520329
Address
1-15-1 kitasato, sagamiharashi-minamiku, nakagawa, Japan
TEL
042-778-8111
hishiyam@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Syunsuke |
| Middle name | |
| Last name | Yamazaki |
Organization
Kitasato University
Division name
Radiation Oncology
Zip code
252-0329
Address
1-15-1 kitasato, sagamiharashi-minamiku, nakagawa, Japan
TEL
042-778-8111
Homepage URL
md14109stku.ac@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
The Ethics Committee of Kitasato University School of Medicine and Hospital
Address
1-15-1 kitasato, sagamiharashi-minamiku, nakagawa, Japan
Tel
042-778-8111
rinri@med.kitasato-u.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
| 2024 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061474
