UMIN-CTR Clinical Trial

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