UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021280 |
|---|---|
| Receipt number | R000024333 |
| Scientific Title | Imaging glucose consumption in skeletal muscles and brain with a high resolution scanner |
| Date of disclosure of the study information | 2016/03/02 |
| Last modified on | 2018/04/04 14:59:14 |
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Basic information
Public title
Imaging glucose consumption in skeletal muscles and brain with a high resolution scanner
Acronym
Muscle imaging with a high resolution scanner
Scientific Title
Imaging glucose consumption in skeletal muscles and brain with a high resolution scanner
Scientific Title:Acronym
Muscle imaging with a high resolution scanner
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at evaluating images of thin skeletal muscles in the forearms and hands of healthy volunteers with scanned with a positron emission mammography (PEM)using [18F]fluorodeoxyglucose (FDG) as a tracer.
Basic objectives2
Others
Basic objectives -Others
This study aims at evaluating images of thin skeletal muscles in the forearms and hands of healthy volunteers with scanned with a positron emission mammography (PEM)using [18F]fluorodeoxyglucose (FDG) as a tracer. The PEM images are compared with those obtained by using a conventional whole-body PET scanner. Spatial resolution of PEM is better than that of whole body PET. If the PEM scanner can visualize the skeletal muscle activity better than a whole body PET, PEM might be able to apply for orthopediac disordrs in hands and forearms. In this study, similar evaluation is to be done also for brain images.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
In this study, images of FDG PEM and FDG PET are compared using a socring system. Spatial resolution of PEM is better than that of whole body PET. If the PEM scanner can visualize the skeletal muscle activity better than a whole body PET, PEM might be able to apply for orthopediac disordrs in hands and forearms. In this study, similar evaluation is to be done also for brain images.
Key secondary outcomes
In addition, standardized uptake value (SUV) is also used as the secondary outcome.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Exercise load on the right digital finger (for 30 min, only once) while the left finger is used as control. Effect of the load is evaluated by FDG uptake in skeletal muscles visualized by PET and PEM scanners.
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1) healthy male volunteers
2) performance status (grade0)
3) 20-40 years old
4) right handed
Key exclusion criteria
1) diabetus melitus
2) allergic reactions
3) cognitive impairment(MMSE<27)
4) those who have felt unconfortable after blood sampling or injections
5) those who have sensitivity to alcohol in their skin upon sterilization
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Tashiro |
Organization
Cyclotron and Radioisotope Center, Tohoku Univeristy
Division name
Div. of Cyclotron Nuclear Medicine
Zip code
Address
Aoba 6-3, Aramaki, Aoba-ku, Sendai, Miyagi
TEL
022-795-7797
mtashiro@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Takeda |
Organization
Cyclotron and Radioisotope Center, Tohoku Univeristy
Division name
Div. of Cyclotron Nuclear Medicine
Zip code
Address
Aoba 6-3, Aramaki, Aoba-ku, Sendai, Miyagi
TEL
022-795-4438
Homepage URL
driving@cyric.tohoku.ac.jp
Sponsor or person
Institute
Cyclotron and Radioisotope Center, Tohoku Univeristy
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sendai Medical Imaging Clinic
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
東北大学サイクロトロン・RIセンター（東北大学病院出張診療所）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 02 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
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
| 2018 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024333
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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