UMIN-CTR Clinical Trial

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

Arthritis

Classification by specialty

Clinical immunology	Orthopedics	Radiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Gunma University

Institute

Department

Personal name

Organization

Gunma University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gunma University

Address

3-39-22, Showa, Maebashi, Gunma, Japan

Tel

+81272208401

Email

sojin@gunma-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

01

Day

URL releasing protocol

https://journals.lww.com/00005792-201706230-00015

Publication of results

Published

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

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 related information

This manuscript of this research was published in Medicine.

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