UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007680
Receipt No. R000009057
Scientific Title Magnetic Resonance Elastography of the Head Using the Gantry Vibration
Date of disclosure of the study information 2012/04/06
Last modified on 2016/06/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Magnetic Resonance Elastography of the Head Using the Gantry Vibration
Acronym Head MRE by Gantry Vibration
Scientific Title Magnetic Resonance Elastography of the Head Using the Gantry Vibration
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Takayuki Obata
Organization National Institute of Radiological Sciences
Division name Research Center for Charged Particle Therapy
Zip code
Address 4-9-1 Anagawa Inage, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University
Division name Graduate School of Engineering
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2012 Year 02 Month 23 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.