UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014466 |
|---|---|
| Receipt number | 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 09:55:43 |
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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
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
okuda@rad.med.keio.ac.jp
Sponsor or person
Institute
Department of Diagnostic Radiology, Keio School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016832
