UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020724 |
|---|---|
| Receipt number | R000023810 |
| Scientific Title | Evaluation of technology and performance of novel free radical imaging system (DNP-MRI) |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2021/10/30 15:37:04 |
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Basic information
Public title
Evaluation of technology and performance of novel free radical imaging system (DNP-MRI)
Acronym
Evaluation of novel free radical imaging system (DNP-MRI)
Scientific Title
Evaluation of technology and performance of novel free radical imaging system (DNP-MRI)
Scientific Title:Acronym
Evaluation of novel free radical imaging system (DNP-MRI)
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate technology and performance of novel free radical imaging system (DNP-MRI)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences between images obtained by field-cycled DNP-MRI achieved by magnet rotation and those by field-cycled MRI, and signal intensities of free radicals deduced from them. Temperature increase of surface coil sites and skin surface during image acquisition.
Key secondary outcomes
Resolution of images obtained by static MRI, resolution of images obtained by field-cycled MRI achieved by magnet rotation.
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
MRI of the hands of healthy volunteers are obtained in both static and field-cycled (with magnetic rotation) mode. Then, the hands are placed near tubes containing free radicals and they are scanned by DNP-MRI to obtain images of free radicals.
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
Key inclusion criteria
Healthy volunteers who understand the study and agree to participate voluntarily.
Key exclusion criteria
1. People who have electrically, magnetically or mechanically activated implants (such as cardiac pacemakers).
2. People who have serious conditions such as cardiac decompensation.
3. Any other people who are regarded as unsuitable for this study by the principal investigator.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Utsumi |
Organization
Kyushu University
Division name
Innovation Center for Medical Redox Navigation
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6155
hideo.utsumi.278@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Tahira |
Organization
Kyushu University
Division name
Innovation Center for Medical Redox Navigation
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6589
Homepage URL
tahira@redoxnavi.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University, Innovation Center for Medical Redox Navigation
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
| 2016 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
doi.org/10.1021/acs.anal.chem.1c02578
Publication of results
Published
Result
URL related to results and publications
doi.org/10.1021/acs.anal.chem.1c02578
Number of participants that the trial has enrolled
3
Results
We developed a novel field-cycling DNP-MRI system for a preclinical study. The image quality was examined using various pulse sequences and ESR irradiation using nitroxyl radical as the phantom, and the optimum conditions were established. Using the system, we performed a preclinical study involving free radical imaging by placing the free radicals under the palm of a human hand.
Results date posted
| 2021 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 05 | Day |
Baseline Characteristics
Three healthy Japanese males (55, 65, and 70 years of age) volunteered for this study.
Participant flow
All volunteers provided informed consent in accordance with the regulation set forth and were approved by the ethical committee of the NPO Clinical Research Network, Fukuoka.
Adverse events
No adverse events was observed.
Outcome measures
Quality of MRI image and the change of temperature at the observation position.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 25 | Day |
Last modified on
| 2021 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023810
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/10/30 | acs.analchem.1c02578.pdf |
