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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044068
Receipt No. R000050313
Scientific Title Functional analysis by upright CT images of muscloskeletal system
Date of disclosure of the study information 2021/04/28
Last modified on 2021/04/28

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Basic information
Public title Functional analysis by upright CT images of muscloskeletal system
Acronym Upright CT images of muscloskeletal system
Scientific Title Functional analysis by upright CT images of muscloskeletal system
Scientific Title:Acronym Upright CT images of muscloskeletal system
Region
Japan

Condition
Condition 1. Asymptomatic Volunteers
2. Patietns with muscloskeletal disease and trauma
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare morphological features for variousanatomical structures in healthy volunteers or muscloskeletal patients who may have a different symptom or an anatomical structure between upright andsupine positions using upright and conventional CT.
Basic objectives2 Others
Basic objectives -Others To explore the relationship between morphological parameters on CT images and clinical data
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Morphological parameters on images
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Normal CT scanner
Interventions/Control_2 Upright CT scanner
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 1. Healthy volunteers (age equal to or more than 20 years)
2. Patients who may have a different symptom or an anatomical structure between the upright and supine positions, and who are referred for conventional CT examination (age equalto or more than 20 years)
3. Subjects who provide written informed consent
Key exclusion criteria 1. Subjects who do not provide written informed consent
2. Known or possible pregnancy
3. Claustrophobia
4. Subjects who are not able to undergo CT examination
5. In case of using iodine contrast agent, subjects with a history of allergy of iodine contrastagent, with asthma, or with impaired renal function
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Jinzaki
Organization School of Medicine, Keio University
Division name Department of Radiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-3353-1977
Email jinzaki@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name Takeo
Middle name
Last name Nagura
Organization School of Medicine, Keio University
Division name Department of Orthopedic Srugery
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3812
Homepage URL
Email nagura@z8.keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
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 IRB Comittee, Keio University
Address 35 Shinanomachi, Shinjuku, Tokyo
Tel 03-5363-3503
Email med-rinri-jimu@adst.keio.ac.jp

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
2021 Year 04 Month 28 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 28 Day
Last modified on
2021 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050313

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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