UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007680 |
|---|---|
| Receipt number | 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 14:57:57 |
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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
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
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009057
