UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036326 |
|---|---|
| Receipt number | R000041385 |
| Scientific Title | Radiotherapy for prostate cancer: Influence of fiducial marker on diffusion weighted MR image |
| Date of disclosure of the study information | 2019/03/28 |
| Last modified on | 2020/12/08 11:21:49 |
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Basic information
Public title
Radiotherapy for prostate cancer: Influence of fiducial marker on diffusion weighted MR image
Acronym
Influence of Gold marker to MRI
Scientific Title
Radiotherapy for prostate cancer: Influence of fiducial marker on diffusion weighted MR image
Scientific Title:Acronym
Influence of Gold marker to MRI
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
If the background of DWI imaging differs by placing a gold marker before radiation treatment, there is a possibility that correct evaluation can not be made. This time we examined prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The MR images taken before and after placement of the gold marker are compared and scored in five steps up to 1-5. If the point difference is large, it is determined that the gold marker affected the MR image. If there is no significant point difference, it is judged that there was no effect.
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
MR image
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Patients who can place gold markers in the prostate
Patients for whom informed consent was obtained
Key exclusion criteria
Patients taking anticoagulant medication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | OSAMU |
| Middle name | |
| Last name | TANAKA |
Organization
Asahi University
Division name
Radiation Oncology
Zip code
5008523
Address
3-23 Hashimoto-cho Gifu
TEL
0582538001
c.bluered@gmail.com
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Tanaka |
Organization
Asahi University Hospital
Division name
Radiation Oncology
Zip code
5008523
Address
3-23 Hashimoto-cho
TEL
0582538001
Homepage URL
c.bluered@gmail.com
Sponsor or person
Institute
Asahi University
Institute
Department
Personal name
Funding Source
Organization
Asahi University
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
Asahi University
Address
3-23 Hashimoto-cho Gifu
Tel
0582538001
c.bluered@gmail.com
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
| 2019 | Year | 03 | Month | 28 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2019 | Year | 03 | Month | 28 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041385
