UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of an influence of measurement posture to image quality of the helmet-type PET scanner
Title of the study (Brief title)	Helmet-PET study for an influence of measurement posture
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effect of measurement posture to the PET image quality by comparing dorsal position and sitting position measurement postures for the helmet-type PET prototype scanner.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quantitative accuracy against a commercial PET/CT scanner comparing sitting style and dorsal style measurement postures.
Key secondary outcomes

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	Intravenous injection of FDG for PET.
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 and Female
Key inclusion criteria	Healthy subjects who have the ability to provide informed consent
Key exclusion criteria	Person who can not understand or agree description document Serious medical illness Person with pacemaker or implant metal Person with tattoo Strong claustrophobia Person of the possibility of a pregnant woman and pregnancy Person within 6 months after the last injection of radioisotopes Person whom the doctor has determined to be inappropriate as a research subject
Target sample size	3

Research contact person
Name of lead principal investigator	Hideaki Tashima
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	National Institute of Radiological Sciences
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-3260
Email	tashima.hideaki@qst.go.jp

Public contact
Name of contact person	Hideaki Tashima
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	National Institute of Radiological Sciences
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-3260
Homepage URL
Email	tashima.hideaki@qst.go.jp

Sponsor
Institute	National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization	National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	放射線医学総合研究所（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 28 Day
Anticipated trial start date	2017 Year 01 Month 30 Day
Last follow-up date	2017 Year 03 Month 30 Day
Date of closure to data entry	2017 Year 03 Month 30 Day
Date trial data considered complete	2017 Year 03 Month 30 Day
Date analysis concluded	2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 19 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029127