UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012492 |
|---|---|
| Receipt number | R000013904 |
| Scientific Title | Evaluation of maximum cross-section of extraocular muscles and orbital fat volume using 3T MRI. |
| Date of disclosure of the study information | 2013/12/04 |
| Last modified on | 2016/12/06 16:55:15 |
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Basic information
Public title
Evaluation of maximum cross-section of extraocular muscles and orbital fat volume using 3T MRI.
Acronym
Evaluation of maximum cross-section of extraocular muscles and orbital fat volume using 3T MRI.
Scientific Title
Evaluation of maximum cross-section of extraocular muscles and orbital fat volume using 3T MRI.
Scientific Title:Acronym
Evaluation of maximum cross-section of extraocular muscles and orbital fat volume using 3T MRI.
Region
| Japan |
Condition
Condition
thyroid-associated ophthalmopathy
extraocular muscular atrophy
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate extraocular muscles and ofbital fat of patients with thyroid-associated ophthalmopathy and extraocular muscular atrophy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
A comparison of maximum cross-section of extraocular muscles and orbital fat volume of patients with thyroid-associated ophthalmopathy at before and after treatment.
Key secondary outcomes
(a) The association between CAS (clinical activity score) and maximum cross-section of extraocular muscles/ orbital fat volume of patients with thyroid-associated ophthalmopathy.
(b) A comparison of maximum cross-section of extraocular muscles between patients with thyroid-associated ophthalmopathy, patients with extraorbital muscular atrophy and controls.
(c) A comparison of orbital fat volume between patients with thyroid-associated ophthalmopathy and controls.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients:
(a) People twenty years old and over at the time of the consent.
(b) patients with thyroid-associated ophthalmopathy of extraorbiral muscular atrophy.
(c) people who don't have other orbital abnormality.
(d) People who can consent to this study in writing.
control:
(a) People twenty years old and over at the time of the consent.
(b) people who don't have any orbital abnormality.
(c) People who can consent to this study in writing.
Key exclusion criteria
(a) Contraindication to MRI(cardiac pacemaker; cochlear implantation device; defibrillator; neurostimulator; bone growth stimulation device; infusion pump; deep brain stimulation; cervical artery crump(Poppen-Blaylock); chip of ferromagnetic substance in eyeball, brain, internal organs, lung, mediastinum; intraaortic filter, intravascular coil or stent within 2 months, claustrophobia, tattoo, pregnancy or likelihood of pregnancy)
(b) People who were unsuitable for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Kaichi |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Diagnostic Radiology
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-5257
kaichi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Kaichi |
Organization
Institute of Biomedical and Health Sciences, Hiroshima University
Division name
Diagnostic Radiology
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-5257
Homepage URL
kaichi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
none.
Organization
Division
Category of Funding Organization
Other
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none.
Management information
Registered date
| 2013 | Year | 12 | Month | 04 | Day |
Last modified on
| 2016 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013904
