UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008871 |
|---|---|
| Receipt number | R000010410 |
| Scientific Title | clinical study of positron emission tomography with 3-deoxy-3-[18F]-fluoro-D-glucose |
| Date of disclosure of the study information | 2012/09/07 |
| Last modified on | 2019/03/12 21:32:41 |
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Basic information
Public title
clinical study of positron emission tomography with 3-deoxy-3-[18F]-fluoro-D-glucose
Acronym
Clinical study in 3FDG-PET
Scientific Title
clinical study of positron emission tomography with 3-deoxy-3-[18F]-fluoro-D-glucose
Scientific Title:Acronym
Clinical study in 3FDG-PET
Region
| Japan |
Condition
Condition
healthy adult volunteer,
cancer, epilepsy, Moyamoya disease,Alzheimer's disease
Classification by specialty
| Hematology and clinical oncology | Neurology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluation of the effectiveness of clinical diagnosis in 3FDG-PET
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visualization of the lesion
Key secondary outcomes
Confirmation of the differences between 3FDG-PET and conventional 2FDG-PET
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
MRI/CT/EEG/clinical examinations
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy volunteers between 20 and 70 years cognitive normal subjects without severe physical complication
patients with cancer diagnosis between 20 and 70 years
Key exclusion criteria
exclude the patients who are recognized as
inadequate patients by doctors with
resposibility in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Nakada |
Organization
University of Niigata
Brain Research Institute
Division name
Center for Integrated Human Brain Science
Zip code
Address
Asahimachi 1-757, Chuo-ku,Niigata
TEL
025-227-0683
tnakada@bri.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Suzuki |
Organization
University of Niigata
Division name
Center for Integrated Human Brain Science
Zip code
Address
Asahimachi 1-757, Chuo-ku,Niigata
TEL
025-227-0683
Homepage URL
yuji-s@bri.niigata-u.ac.jp
Sponsor or person
Institute
Center for Integrated Human Brain Science,
Brain Research Institute, University of Niigata
Institute
Department
Personal name
Funding Source
Organization
grant from Ministry of Education, Culture, Sports, Science
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 09 | Month | 07 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2007 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 06 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010410
| Research Plan | |
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| Registered date | File name |
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