UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009917 |
|---|---|
| Receipt number | 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 09:49:25 |
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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
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
tsucchy@u-fukui.ac.jp
Sponsor or person
Institute
Department of Radiology, University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011621
