UMIN-CTR Clinical Trial

Basic information
Public title	The assessment of lesion detection capability and FDG uptake value by digital PET/CT
Acronym	The assessment of lesion detection capability and FDG uptake value by digital PET/CT
Scientific Title	The assessment of lesion detection capability and FDG uptake value by digital PET/CT
Scientific Title:Acronym	The assessment of lesion detection capability and FDG uptake value by digital PET/CT
Region	Japan

Condition
Condition	Malignancy, vasculitis, cardiac sarcoidosis, etc.
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare lesion detection capability and differences in quantitative values such as standardized uptake value(SUV) between a digital and an analog PET/CT system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lesion detection capability
Key secondary outcomes	SUVmax of the lesions and Physiological Accumulation,image quality

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 receive a intravenous administration of FDG as in the usual PET scan. Patients undergo the digital PET/CT scan (Discovery Mi-AM edition, GE Healthcare) and then on the analog PET scan (Discovery 600 PET/CT, GE Healthcare) 60 minutes after FDG administration.
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	Patients who obtained written consent before PET/CT.
Key exclusion criteria	1) Patients who have difficulty remaining still during PET/CT scan. 2) Patients who have undergone multiple PET/CT scans by the same imaging protocol during the study period and have already been included in this study. 3) Other patients who are judged to be unsuitable for this study by the study physician.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tomohisa Middle name Last name Okada
Organization	Ehime University graduate school of medicine
Division name	Department of radiology
Zip code	791-0204
Address	Ehime Prefecture Toon City Shitsukawa
TEL	089-964-5111
Email	okada.tomohisa.ue@ehime-u.ac.jp

Public contact
Name of contact person	1st name Tomohisa Middle name Last name Okada
Organization	Ehime University graduate school of medicine
Division name	Department of radiology
Zip code	791-0204
Address	Ehime Prefecture Toon City Shitsukawa
TEL	089-964-5111
Homepage URL
Email	okada.tomohisa.ue@ehime-u.ac.jp

Sponsor
Institute	Ehime University
Institute
Department

Funding Source
Organization	Ehime University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board ,Ehime University Hospital
Address	Shitsukawa, Toon, Ehime, Japan
Tel	089-960-5914
Email	rinri@m.ehime-u.ac.jp

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	2020 Year 04 Month 01 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	Enrolling by invitation
Date of protocol fixation	2020 Year 01 Month 29 Day
Date of IRB	2020 Year 03 Month 23 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 31 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045615

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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