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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040015
Receipt No. R000045615
Scientific Title The assessment of lesion detection capability and FDG uptake value by digital PET/CT
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/31

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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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