UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038390 |
|---|---|
| Receipt number | R000043748 |
| Scientific Title | Study for the determining factor of arterial FDG uptake in inflammatory arterial diseases. |
| Date of disclosure of the study information | 2019/10/25 |
| Last modified on | 2022/04/27 19:50:31 |
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Basic information
Public title
Study for the determining factor of arterial FDG uptake in inflammatory arterial diseases.
Acronym
FDG uptake in inflammatory arterial diseases.
Scientific Title
Study for the determining factor of arterial FDG uptake in inflammatory arterial diseases.
Scientific Title:Acronym
FDG uptake in inflammatory arterial diseases.
Region
| Japan |
Condition
Condition
inflammatory arterial diseases
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysing the factors which determine arterial wall uptake of FDG.
Basic objectives2
Others
Basic objectives -Others
Evaluation of ethiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between FDG uptake on arterial wall and other biological parameters.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with large vessel vasculitis, IgG4-related disorder and polymyalgia rheumatica
Key exclusion criteria
Patient who showed glucose level over 250mg/dl at the time of FDG PET examination.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kudo |
Organization
Nagasaki University
Division name
Dept.of Radioisotope medicine, Atomic bomb disease institute.
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki
TEL
0958197101
tkudo123@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kudo |
Organization
Nagasaki University
Division name
Dept.of Radioisotope medicine, Atomic bomb disease institute.
Zip code
8528523
Address
1-12-4 Sakamoto, Nagasaki
TEL
0958197101
Homepage URL
tkudo123@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
IRB of Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | 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
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2019 | Year | 10 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043748
