UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of MRI pulse sequences in defining outline of prostate and gold fiducial marker for CT/MRI fusion of IMRT for prostate cancer
Title of the study (Brief title)	Comparisopn of MRI pulse sequences for ideal prostate IMRT
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To find an ideal MRI sequences comparing T1-weighted image, T2-weighted image, T2*3D-weighted and contrast enhanced T1-weighted image. It includes the outline of prostate and gold fiducial marker in prostate. Blinded 2 observers score the quality of images individually.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Finding of an ideal MRI sequences from scoring T1-weighted image, T2-weighted image, T2*3D-weighted and contrast enhanced T1-weighted image by blinded 2 observers.
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	Maneuver
Interventions/Control_1	Magnetic resonance imaging
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	The eligibility of this study is given by informed consent to enroll this study.
Key exclusion criteria	No available
Target sample size	30

Research contact person
Name of lead principal investigator	Osamu Tanaka
Organization	Gifu Municipal Hospital
Division name	Radiation Oncology
Address	7-1 Kashima-cho Gifu
TEL	81-58-251-1101
Email	osa0508@yahoo.co.jp

Public contact
Name of contact person	Osamu Tanaka
Organization	Gifu Municipal Hospital
Division name	Radiation Oncology
Address	7-1 Kashima-cho Gifu
TEL	81-58-251-1101
Homepage URL
Email	osa0508@yahoo.co.jp

Sponsor
Institute	Gifu Municipal Hospital
Institute
Department

Funding Source
Organization	Gifu Municipal Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	岐阜市民病院

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 17 Day
Anticipated trial start date	2015 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	prospective study. The patients are treated in our hospital. Observing time is between 2015 October to 2016 March.The patients give their written informed consent.

Management information
Registered date	2015 Year 10 Month 03 Day
Last modified on	2018 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022215