UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013592 |
|---|---|
| Receipt number | R000015882 |
| Scientific Title | Utility of Xiralite Fluorescence Imaging System *4in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2023/02/17 15:48:49 |
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Basic information
Public title
Utility of Xiralite Fluorescence Imaging System *4in patients with rheumatoid arthritis
Acronym
Utility of Xiralite
Scientific Title
Utility of Xiralite Fluorescence Imaging System *4in patients with rheumatoid arthritis
Scientific Title:Acronym
Utility of Xiralite
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I examine the relevance of ultrasound and Xiralite in joint assessment by comparing Xiralite with ultrasound in patients with RA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association with ultrasound and Xiralite in joint assessment of RA patients
Key secondary outcomes
Association with the image findings and blood biomarkers
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
I perform an intravenous injection of ICG and evaluate arthritis of both hands using Xiralite.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The patients with RA visiting in our hospital (hospitalization and outpatient)
2.The patients that agree participation of clinical study
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kawashiri |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Zip code
Address
1-7-1Sakamoto,Nagasaki
TEL
095-819-7067
shin-ya@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Kawashiri |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Zip code
Address
1-7-1Sakamoto,Nagasaki
TEL
095-819-7067
Homepage URL
shin-ya@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2014 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000015882
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33084461/
Number of participants that the trial has enrolled
50
Results
https://pubmed.ncbi.nlm.nih.gov/33084461/
Results date posted
| 2023 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/33084461
Participant flow
https://pubmed.ncbi.nlm.nih.gov/33084461/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/33084461/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/33084461/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015882
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
