UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Imaging glucose consumption in skeletal muscles and brain with a high resolution scanner
Title of the study (Brief title)	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	Manabu Tashiro
Organization	Cyclotron and Radioisotope Center, Tohoku Univeristy
Division name	Div. of Cyclotron Nuclear Medicine
Address	Aoba 6-3, Aramaki, Aoba-ku, Sendai, Miyagi
TEL	022-795-7797
Email	mtashiro@m.tohoku.ac.jp

Public contact
Name of contact person	Kazuko Takeda
Organization	Cyclotron and Radioisotope Center, Tohoku Univeristy
Division name	Div. of Cyclotron Nuclear Medicine
Address	Aoba 6-3, Aramaki, Aoba-ku, Sendai, Miyagi
TEL	022-795-4438
Homepage URL
Email	driving@cyric.tohoku.ac.jp

Sponsor
Institute	Cyclotron and Radioisotope Center, Tohoku Univeristy
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024333