UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of glucose metabolism of small skeletal muscles with PET/MR scanner
Title of the study (Brief title)	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	Manabu TASHIRO
Organization	Tohoku Univeristy
Division name	Cyclotron and Radioisotope Center
Address	6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL	022-795-7797
Email	mtashiro@m.tohoku.ac.jp

Public contact
Name of contact person	Kazuko Takeda
Organization	Tohoku Univeristy
Division name	Cyclotron and Radioisotope Center
Address	6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL	022-795-4438
Homepage URL
Email	driving@cyric.tohoku.ac.jp

Sponsor
Institute	Tohoku Univeristy Cyclotron and Radioisotope Center
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035426