UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021296 |
|---|---|
| Receipt number | R000022013 |
| Scientific Title | Development of high-grade clinical imaging methods using a 7T-MRI system |
| Date of disclosure of the study information | 2016/03/02 |
| Last modified on | 2023/09/07 10:55:02 |
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Basic information
Public title
Development of high-grade clinical imaging methods using a 7T-MRI system
Acronym
Development of clinical imaging methods for a 7T-MRI system
Scientific Title
Development of high-grade clinical imaging methods using a 7T-MRI system
Scientific Title:Acronym
Development of clinical imaging methods for a 7T-MRI system
Region
| Japan |
Condition
Condition
Healthy and patient volunteers
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of clinically useful measurement methods by making most of the 7T-MRI system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Establishing clinical advantage of the 7T-MRI system including comparison with the 3T-MRI system.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Exploratory scans will be conducted using 7T-MRI to investigate anatomical and functional images for 1 to several times. If necessary, 3T scans will also be conducted. After these scans, image quality will be evaluated using subjective scores by radiologists and other indexes.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Volunteers aged from 20 to 70 who gave written informed consent after explanation of this study.
Key exclusion criteria
When subjects are contra-indicated of MRI examination.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Okada |
Organization
Graduate School of Medicine, Kyoto University.
Division name
Human Brain Research Center
Zip code
606-8507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
0757513695
tomokada@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Okada |
Organization
Graduate School of Medicine, Kyoto University.Kyoto University
Division name
Human Brain Research Center
Zip code
606-8507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
0757513695
Homepage URL
tomokada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Human Brain Research Center, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Siemens Healthcare Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Siemens Healthcare KK
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committee
Address
Yoshida Konoecho, Skayoku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs052180204
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
https://hbrc.med.kyoto-u.ac.jp/?page_id=100
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35655840/
Number of participants that the trial has enrolled
860
Results
Measurement stability of anatomical images were observed using quantitative values. It was relatively low at the skull base, but it was high at the convexity. Age-related changes were different among brain areas and quantitative values as well. MRS could detect more neurochemicals than 3T. Macromolecules are nuisance for quantitation, and they were measured in vivo and analysis parameters were optimized. Analysis method focused on alpha-glucose was also investigated.
Results date posted
| 2022 | Year | 09 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects and patients
Participant flow
Enrollment based on local advertisement.
Adverse events
No adverse events, such as vertigo and burn, that require treatment was observed.
Outcome measures
Evaluate image quality compared with 3T images or images with different scan parameters.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022013
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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