UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015691 |
|---|---|
| Receipt number | R000018236 |
| Scientific Title | Comparison between FDG, methionine, and 4DST PET in patients with arthritis and vasculitis |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2014/11/14 12:20:53 |
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Basic information
Public title
Comparison between FDG, methionine, and 4DST PET in patients with arthritis and vasculitis
Acronym
Evaluation of inflammatry diseases using 3 PET tracers
Scientific Title
Comparison between FDG, methionine, and 4DST PET in patients with arthritis and vasculitis
Scientific Title:Acronym
Evaluation of inflammatry diseases using 3 PET tracers
Region
| Japan |
Condition
Condition
collagen diseases(arthritis vasculitis)
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of diagnostic ability Prediction of therapeutic effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation PET uptake with clinical manifestations during pre- and post-treatments
Key secondary outcomes
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
| Medicine | Device,equipment | Other |
Interventions/Control_1
PET examinations(FDG,methionine,4DST)
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
1.Patients suspected collagen disease by specialists.
2.Patients who were 20 years old or older when they signed the informed consent form.
Key exclusion criteria
1.Pregnant or lactating patients.
2.Patients with severe immunosuppression.
3.Patients with malignancies.
4.Patients who were suspected of not being able to provide full voluntary agreement to participate in this research study because of mental and/or legal problems,etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiteru Ito |
Organization
Tokyo metropolitan Geriatric Hospital and institute of Gerontology
Division name
Department of Diagnostic Radiology
Zip code
Address
35-2 Sakae-cho Itabashi-Ku Tokyo
TEL
03-3964-1141(62197)
itoukimiteru@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiteru Ito |
Organization
Tokyo metropolitan Geriatric Hospital and institute of Gerontology
Division name
Department of Diagnostic Radiology
Zip code
Address
35-2 Sakae-cho Itabashi-Ku Tokyo
TEL
03-3964-1141(62197)
Homepage URL
itoukimiteru@yahoo.co.jp
Sponsor or person
Institute
Tokyo metropolitan Geriatric Hospital and institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Tokyo metropolitan Geriatric Hospital and institute of Gerontology
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 06 | 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
| 2014 | Year | 11 | Month | 14 | Day |
Last modified on
| 2014 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018236
| 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 |
