UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008518 |
|---|---|
| Receipt number | R000010007 |
| Scientific Title | FDG PET brain images of the patients with HIV |
| Date of disclosure of the study information | 2012/07/25 |
| Last modified on | 2017/05/22 09:06:21 |
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Basic information
Public title
FDG PET brain images of the patients with HIV
Acronym
FDG PET brain images of the patients with HIV
Scientific Title
FDG PET brain images of the patients with HIV
Scientific Title:Acronym
FDG PET brain images of the patients with HIV
Region
| Japan |
Condition
Condition
HIV related disease
Classification by specialty
| Neurology | Infectious disease | Psychiatry |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of 18F-FDG PET for diagnosis of HIV related cognitive disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
18F-FDG PET could detect the mild cognitive disorder of the patients with HIV.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Key inclusion criteria
1. HIV positive
2.age>20 years old.
3.capabity to have PET scan
4.completed the written infrmed consent.
Key exclusion criteria
1.unable to have signed infrmed consent.
2.Patients with severe underlying disease haveing risk of liver dysfunction, renal dysfunction and any metabolic damage.
3.just after surgery and/or brain trauma
4.uncontrolled diabeics
5.Those who are determined as not appropriate for the study by physician in chief.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
National Center for Global Health and Medicine
Division name
Radiology
Zip code
Address
1-21-1,Toyama, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
rminamimoto@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
National Center for Global Health and Medicine
Division name
Radiology
Zip code
Address
1-21-1, Toyama, Shinjuku, Tokyo
TEL
03-3202-7181
Homepage URL
rinrijm@hosp.ncgm.go.jp
Sponsor or person
Institute
National Centerf for Global Health and Medicine.
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Tokyo Metroporitan institue for Genontology.
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 | 07 | Month | 25 | 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 | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 07 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 07 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
FDG PET, MRI, and the neuropsychological tests are performed and the findings are compared to normal.
Management information
Registered date
| 2012 | Year | 07 | Month | 24 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010007
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
