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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036326
Receipt No. 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 2019/03/28

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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
Email 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
Email c.bluered@gmail.com

Sponsor
Institute Asahi University
Institute
Department

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
Email 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 Open public recruiting
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
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041385

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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