UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Magnetic Resonance Elastography of the Head Using the Gantry Vibration
Title of the study (Brief title)	Head MRE by Gantry Vibration
Region	Japan

Condition
Condition	Healthy individuals
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate relationship between age and elasticity of the head and neck tissue by MR elastography using the gantry vibration.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between age and elasticity of the head and neck tissue by MR elastography using the gantry vibration.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	test-retest and age affection
Interventions/Control_2	Magnetic resonance elastography (MRE)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	1. Subjects who have ability to provide informed consent. 2. Women who are 20 and 59 years old at the time of obtaining informed consent 3. Subjects who have been judged there are no problems with the health by the attending physician from inspection, physical examination and clinical examination.
Key exclusion criteria	1. Subjects who have serious diseases such as diabetes, hypertension and cerebrovascular disease. 2. Subjects who have drug or alcohol dependence. 3. Subjects who judged inappropriate as a subject by the investigators.
Target sample size	30

Research contact person
Name of lead principal investigator	Takayuki Obata
Organization	National Institute of Radiological Sciences
Division name	Research Center for Charged Particle Therapy
Address	4-9-1 Anagawa Inage, Chiba
TEL
Email

Public contact
Name of contact person
Organization	Chiba University
Division name	Graduate School of Engineering
Address
TEL
Homepage URL
Email

Sponsor
Institute	National Institute of Radiological Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Research Grant-in-Aid for Scientific Research Ministry of Education, Culture, Sports, Science
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 23 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 06 Day
Last modified on	2016 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009057