UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031020 |
|---|---|
| Receipt number | R000035426 |
| Scientific Title | Measurement of glucose metabolism of small skeletal muscles with PET/MR scanner |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2019/01/27 17:12:32 |
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Basic information
Public title
Measurement of glucose metabolism of small skeletal muscles with PET/MR scanner
Acronym
PET/MR study on small muscles
Scientific Title
Measurement of glucose metabolism of small skeletal muscles with PET/MR scanner
Scientific Title:Acronym
PET/MR study on small muscles
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study is to visualize the energy consumption of small skeletal muscles in hands and arms and head and face regions.
1) functional imaging of skeletal muscles in hands and arms: Muscles in hands and arms are very small. It has been hard to observe such small muscles using FDG PET. But using PET/MR, it might be possible to measure precisely. Additional purpose is to examine the relationship between the FDG uptake and EMG and digid force data.
2) Also the muscles in head region and face are very small. Addtional purpose of this study is to investigate the activity of facial muscles in some facial expression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
*Standardized Uptake Value (SUV) as an index of glucose consumption, measured by positron emission tomography (PET).
Key secondary outcomes
*Electromyography (EMG) data as an idex of muscle contraction.
*Digit forces of thumb, pointing fingers, middle fingers.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
*finger tapping task for 30 min following FDG injection (n=6).
Interventions/Control_2
*hand writing task for 30 min following FDG injection (n=6).
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1) healthy adult men
2) Performance Status (grade0)
3) 20 to 40 years old
4) right handed
Key exclusion criteria
1) Person who has contra-indications to MR examination
2) Person who has allgies to drugs and foods, etc. (including hypersensitivity to alcohol)
3) Person who became ill following injection and infusion.
4) Person who has had experiences of serving as a research volunteer of certain clinical studies in which radiation exposures are given to the subjects (such as other PET studies).
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu TASHIRO |
Organization
Tohoku Univeristy
Division name
Cyclotron and Radioisotope Center
Zip code
Address
6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL
022-795-7797
mtashiro@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Takeda |
Organization
Tohoku Univeristy
Division name
Cyclotron and Radioisotope Center
Zip code
Address
6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL
022-795-4438
Homepage URL
driving@cyric.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Univeristy
Cyclotron and Radioisotope Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukushima Prefectural Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2017-2-237
Org. issuing International ID_1
Clinical Research Ethics Committee of Tohoku University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学サイクロトロン・RIセンター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 26 | Day |
Last modified on
| 2019 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035426
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
