UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the image quality and the quantitative accuracy of PET images obtained from the flexible PET device
Title of the study (Brief title)	Evaluation of the image quality and the quantitative accuracy of PET images obtained from the flexible PET device
Region	Japan

Condition
Condition	Malignant tumors except for early gastric cancer Epilepsy Cardiac sarcoidosis
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The flexible PET device (fxPET), which allows us to fit a bed of imaging modalities and patients of various body sizes, has been developed. The purpose of this study is to evaluate the quantitative accuracy and image quality of fxPET images with attenuation correction performed by means of CT data obtained from whole-body PET/CT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The quantitative accuracy will be assessed by evaluating the relationship between the standardized uptake values (SUVs) of fxPET and those of whole-body PET/CT.
Key secondary outcomes	The image quality of fxPET images will be analysed visually by two board-certified nuclear medicine physicians by means of a 4-point grading scale.

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	Device,equipment
Interventions/Control_1	Patients, who are suspected malignancy, undergo a whole-body PET/CT scan, and an additional scan by fxPET.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients who are going to undergo the PET/CT with applied health insurance and agree to sign the written consent form of the study 2)Patients who are over 20 years of age and more when they are registered in the study
Key exclusion criteria	1) Patients who disagree to take part in the study 2) Patients who are under 20 years old
Target sample size	150

Research contact person
Name of lead principal investigator	Togashi Kaori
Organization	Kyoto University
Division name	Department of Diagnostic Imaging and Nuclear Medicine Graduate School of Medicine
Address	54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-city
TEL	075-751-3760
Email	ktogashi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Ryusuke Nakamoto
Organization	Kyoto University
Division name	Department of Diagnostic Imaging and Nuclear Medicine Graduate School of Medicine
Address	54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-city
TEL	075-751-3760
Homepage URL
Email	inabook@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Ministry of Education
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 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 05 Month 03 Day
Last modified on	2017 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025559