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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012492
Receipt No. 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

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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
Email 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
Email kaichi@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013904

Research Plan
Registered date File name
2016/06/06 臨床研究実施計画書_1124.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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