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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014466
Receipt No. R000016832
Scientific Title Tuning up parameters in newly-developed MRI sequences for body imaging
Date of disclosure of the study information 2014/07/07
Last modified on 2015/05/01

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Basic information
Public title Tuning up parameters in newly-developed MRI sequences for body imaging
Acronym Tuning up parameters in body MRI sequences
Scientific Title Tuning up parameters in newly-developed MRI sequences for body imaging
Scientific Title:Acronym Tuning up parameters in body MRI sequences
Region
Japan

Condition
Condition Healthy young people
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To adjust imaging parameters for newly-developed the body MRI sequences.
Basic objectives2 Others
Basic objectives -Others To evaluate the image quality.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To find optimized imaging parameters.
Key secondary outcomes To evaluate the quality of the images acquired using newly-developed sequences.

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
35 years-old >=
Gender Male and Female
Key inclusion criteria Healthy volunteers
Key exclusion criteria 1. Pregnancy or suggestive of pregnancy
2. Implanted electorical, megnetical or mechanical device in the body
3. Claustrophobia
4. There are non-compliant items in the questionaries.
5. A participant in any other clinical study
6. Person who is ruled unfit to be a participant in this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Okuda
Organization Keio University School of Medicine
Division name Department of Diagnosntic Radiology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-5363-3837
Email okuda@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Okuda
Organization Keio University School of Medicine
Division name Department of Diagnostic Radiology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-3225-5715
Homepage URL
Email okuda@rad.med.keio.ac.jp

Sponsor
Institute Department of Diagnostic Radiology, Keio School of Medicine
Institute
Department

Funding Source
Organization GE Healthcare Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2014 Year 07 Month 07 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
Healthy adult volunteer studies were performed with written informed consent, for tuning up image acquisition parameters of newly-developed sequences before clinical usage.  We tried synthesized diffusion and brachial plexus imaging. Images obtained with synthetic DWI was equivalent to direct imaging. For brachial plexus images, cube-black blood was superior to other imaging techniques for depicting neural fibers.
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
2014 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 07 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 06 Month 30 Day

Other
Other related information Acquired image data will be evaluated.

Management information
Registered date
2014 Year 07 Month 03 Day
Last modified on
2015 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016832

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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