UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system
Acronym	An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system
Scientific Title	An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system
Scientific Title:Acronym	An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system
Region	Japan

Condition
Condition	Rheumatic diseases (rheumatoid arthritis, polymyalgia rheumatica, palindromic rheumatism, RS3PE syndrome, Sjogren's syndrome, psoriatic arthritis, seronegative spondyloarthropathy, systemic connective tissue disease).
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the imaging capability of synovitis (blood flow in the synovial hypertrophy) in joints, synovial bursa or tendon sheath using a photoacoustic imaging system for undifferentiated arthritis and rheumatic diseases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Contrast and volume of photoacoustic images corresponding to synovitis (blood flow in the synovial hyperplasia) in joints, synovial bursa or tendon sheath for undifferentiated arthritis and rheumatic diseases.
Key secondary outcomes	Incidence of adverse events by using the photoacoustic imaging system. (Final monitoring is conducted within 90 days after intervention)

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Photoacoustic Imaging (Use of the device is for up to three days)
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	1. Patients with undifferentiated arthritis and rheumatic disease (rheumatoid arthritis, polymyalgia rheumatica, palindromic rheumatism, RS3PE syndrome, Sjogren's syndrome, psoriatic arthritis, seronegative spondyloarthropathy, systemic connective tissue disease) those who were enrolled in KURAMA cohort study. 2. Patients who aged over 20 years and older at the time of informed consent. 3. Patients who have agreed to participate in this study from their own free will with document consents.
Key exclusion criteria	1. Pregnant and lactating patients 2. Patients who takes photosensitizer for photodynamic therapy 3. Patients with a cardiac pacemaker 4. Patients who are in poor general status 5. People who have any following complications in assessment body parts: Open wounds, excoriations, acnes, surgical wounds. Infected wounds. Infections. Neurological diseases and orthopedic disorders in which it is impossible to keep sitting or standing position. 6. People who have any following history of disorders: Mental disorders. Dementia. 7. Patients who are judged ineligible to enroll into this clinical study by the investigator or the sub-investigators due to communication difficulty, limitations in taking examination position and other reasons.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Shuichi Middle name Last name Matsuda
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Orthopaedic Surgery
Zip code	606-8507
Address	54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3366
Email	seikei@kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person	1st name Kouichi Middle name Last name Murata
Organization	Graduate School of Medicine Kyoto University
Division name	Department of the Control for Rheumatic Diseases
Zip code	606-8507
Address	54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3366
Homepage URL
Email	morifuru@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Cabinet Office
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Canon Inc.
Name of secondary funder(s)	Canon Inc.

IRB Contact (For public release)
Organization	Kyoto University Hospital Ethics Committe
Address	Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
Tel	0757534680
Email	ethcom@kuhp.kyoto-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 09 Month 13 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	14
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	2016 Year 06 Month 15 Day
Date of IRB	2016 Year 09 Month 08 Day
Anticipated trial start date	2016 Year 09 Month 08 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 06 Month 27 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026342