UMIN-CTR Clinical Trial

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
Email	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
Email	sojin@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028842