UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022735 |
|---|---|
| Receipt number | R000026192 |
| Scientific Title | Clinical value of whole-body PET/CT in patients with active rheumatic diseases. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2019/12/18 01:05:47 |
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Basic information
Public title
Clinical value of whole-body PET/CT in patients with active rheumatic diseases.
Acronym
Clinical value of whole-body PET/CT in patients with active rheumatic diseases.
Scientific Title
Clinical value of whole-body PET/CT in patients with active rheumatic diseases.
Scientific Title:Acronym
Clinical value of whole-body PET/CT in patients with active rheumatic diseases.
Region
| Japan |
Condition
Condition
Rheumatic diseases
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate The utility of FDG-PET/CT in activity and diagnosis of rheumatic diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FDG uptake in site of lesion (visual assessment, SUV quantification)
Key secondary outcomes
Disease activity
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 |
Interventions/Control_1
FDG-PET/CT
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have rheumatic diseases or are suspected to have rheumatic diseases.
Patients who agree and write informed consentform
Age>18 year-old
Key exclusion criteria
Pregnancy
Patient who can not keep still during the examination
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamashita |
Organization
National Center for Global Health and Medicine
Division name
Division of Rheumatic Diseases
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo-to,Japan
TEL
03-3202-7181
hiroyuki_yjp2005@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamashita |
Organization
National Center for Global Health and Medicine
Division name
Division of Rheumatic Diseases
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo-to,Japan
TEL
03-3202-7181
Homepage URL
hiroyuki_yjp2005@yahoo.co.jp
Sponsor or person
Institute
Division of Rheumatic Diseases, National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Rheumatic Diseases, National Center for Global Health and Medicine
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
Ethical Committee, National Center for Global Health and Medicine
Address
1-21-1 Toyama Shinjuku-ku, Tokyo-to,Japan
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.jp
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
国立国際医療研究センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026192
