UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025071 |
|---|---|
| Receipt number | R000028842 |
| Scientific Title | Diagnostic values of 18F-fluorodeoxyglucose uptake parameters for differentiation between rheumatoid arthritis and seronegative spondyloarthopathy |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2021/03/25 09:46:53 |
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Basic information
Public title
Diagnostic values of 18F-fluorodeoxyglucose uptake parameters for differentiation between rheumatoid arthritis and seronegative spondyloarthopathy
Acronym
FDG-PET for patients with rheumatoid arthritis and non specific arthritis
Scientific Title
Diagnostic values of 18F-fluorodeoxyglucose uptake parameters for differentiation between rheumatoid arthritis and seronegative spondyloarthopathy
Scientific Title:Acronym
FDG-PET for patients with rheumatoid arthritis and non specific arthritis
Region
| Japan |
Condition
Condition
Arthritis
Classification by specialty
| Clinical immunology | Orthopedics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the volumetric parameters of 18F-FDG PET for differentiation of rheumatoid arthritis (RA) from non-rheumatoid arthritis (Non-RA).
Basic objectives2
Others
Basic objectives -Others
Diagnostic accuracy for rheumatoid arthritis by FDG-PET
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study involved patients, who had rheumatoid arthritis or seronegative arthopathy (Non-RA). The FDG PET images were taken 1 hour after injection of 18F-FDG and scanned from head to toe in arms down position using a PET-CT scanner. FDG uptake was analyzed visually in each joint using Visual Scoring System (VS) from Score 1 to Score 5 and quantified as maximum SUV (SUVmax) in a standard region of interest. A total of 12 joints were evaluated in each patient. Metabolic parameters, metabolic active volume (MAV) and total lesion glycolysis (MAV X SUVmean) was also calculated. Each sum of Visual score (total visual score), SUVmax (total SUVmax), MAV (total MAV), and total lesion glycolysis (total TLG) was calculated for each patient. Thresholds to measure MAVs and TLGs were decided by ROC analysis based on the comparison with VS and SUVmax. All the parameters were compared between RA and Non-RA group.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent FDG-PET for the following purpose:
1. Clinical trial: FDG-PET for rheumatoid arthritis
2. Patient with non rheumatoid arthritis who underwent FDG-PET for suspicion of malignancy
Key exclusion criteria
Patients without arthritis
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Nakajima |
| Middle name | |
| Last name | Takahito |
Organization
Gunma University
Division name
Diagnostic Radiology and Nuclear Medicine
Zip code
3718511
Address
3-39-22, Showa, Maebashi, Gunma, Japan
TEL
027-220-8401
sojin@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Nakajima |
| Middle name | |
| Last name | Takahito |
Organization
Gunma University Hospital
Division name
Diagnostic Radiology and Nuclear Medicine
Zip code
3718511
Address
3-39-22, Showa, Maebashi, Gunma, Japan
TEL
027-220-8401
Homepage URL
sojin@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University
Address
3-39-22, Showa, Maebashi, Gunma, Japan
Tel
+81272208401
sojin@gunma-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
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.lww.com/00005792-201706230-00015
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/00005792-201706230-00015
Number of participants that the trial has enrolled
35
Results
This manuscript of this research was published in Medicine.
Results date posted
| 2021 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
18 patients were diagnosed as cases of RA based on American College of Rheumatology (ACR) revised criteria 1987
17 patients who had presented with arthritis and did not qualify the ACR criteria for RA were categorized as aseptic arthritis other than RA (non-RA)
Participant flow
A retrospective study
Adverse events
n.a.
Outcome measures
Correlations between metabolic tumor volume (MTV), or total lesion glycolysis (TLG) and clinical indicators
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This manuscript of this research was published in Medicine.
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028842
