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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009917
Receipt No. R000011621
Scientific Title Research about the image quality of FDG-PET-relationship of the interval between meal and FDG injecion and a-glucosidase inhibitor-
Date of disclosure of the study information 2013/02/01
Last modified on 2013/09/05

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Basic information
Public title Research about the image quality of FDG-PET-relationship of the interval between meal and FDG injecion and a-glucosidase inhibitor-
Acronym Research about the image quality of FDG-PET
Scientific Title Research about the image quality of FDG-PET-relationship of the interval between meal and FDG injecion and a-glucosidase inhibitor-
Scientific Title:Acronym Research about the image quality of FDG-PET
Region
Japan

Condition
Condition Normal volunteer
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate how the effect of the interval between meal and FDG injection, and a-glucosidase inhibitor will affect the image quality of FDG-PET.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Image quality
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 a-glucosidase inhibitor
Interventions/Control_2 interval between meal and FDG injection
Interventions/Control_3 Control
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

Not applicable
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria Normal heathy volunteer (male) without a past history of diabetes mellitus.
Key exclusion criteria diabetes mellitus
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuro Tsuchida
Organization University of Fukui Hospital
Division name Department of Radiology
Zip code
Address 23-3, Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL 0776-61-3111
Email tsucchy@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuro Tsuchida
Organization University of Fukui Hospital
Division name Department of Radiology
Zip code
Address 23-3, Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL 0776-61-3111
Homepage URL
Email tsucchy@u-fukui.ac.jp

Sponsor
Institute Department of Radiology, University of Fukui
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2013 Year 02 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 Terminated
Date of protocol fixation
2013 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 31 Day
Last modified on
2013 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011621

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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