UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022896 |
|---|---|
| Receipt number | R000026342 |
| Scientific Title | An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system |
| Date of disclosure of the study information | 2019/09/13 |
| Last modified on | 2019/03/13 17:01:11 |
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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
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
seikei@kuhp.kyoto-u.ac.jp
Public contact
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
morifuru@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026342
| Research Plan | |
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| Registered date | File name |
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