Rheumatoid ArthritisNCT04297475
The Clinical Feasibilityof a Multi-modal Photoacoustic/Ultrasonic Imaging System in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
New type of imaging method is in demand clinically for early detection and treatment guiding of RA. Photoacoustic imaging (PAI), a hot spot in medical imaging society, which combines the merits of optical imaging and US and has a capacity in morphological, functional and molecular imaging, has shown potential in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Ultrasonography
- What is being tested?
- Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The RA patients are diagnosed as RA by two experienced rheumatologists.
The inclusion criteria
- The patients were above 18 years-old;
- The patients were diagnosed with RA according to the American College of Rheumatology (ACR) criteria, and the current clinical state was in-active or relapse;
- The patients were consent to receive examinations of photoacoustic imaging.
The exclusion criteria
- The patients had mental disease or other severe diseases, and were not capable of receiving imaging examinations;
- The patients had strong reaction to laser light.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Meng Yang, Doctor, 8601069155494 ext. 8601069155494, yangmeng@pumch.cn
Meng Yang, Doctor
About this study
Official title: The Clinical Feasibility and Added Value of a Multi-modal Photoacoustic/Ultrasonic Imaging System in the Evaluation of Rheumatoid Arthritis
New type of imaging method is in demand clinically for early detection and treatment guiding of RA. Photoacoustic imaging (PAI), a hot spot in medical imaging society, which combines the merits of optical imaging and US and has a capacity in morphological, functional and molecular imaging, has shown potential in visualizing superficial organs, including small joints. The investigators developed a multi-modal photoacoustic/ultrasound (PA/US) imaging system, equipped with a handheld 3D PA/US probe, which wass able to provide 3D volume data of dual-wavelength PA imaging of small joints, in addition to real-time 2D PA/US imaging. The investigators plan to recruit RA patients in different disease conditions and healthy volunteers to receive the 2D and 3D PA/US examination on the 2nd and 3rd MCP, PIP joints and wrist joints using this imaging system, and to evaluate the potential clinical role of the imaging system in RA, and its added value to current imaging methods.
Read the detailed description
The multi-modal PA/US imaging system was built on a high-end commercial US platform, and allowed real-time imaging of grey-scale US imaging, Color-Doppler US (CDUS) imaging and dual-wavelength PA imaging. The PA/US images were acquired using a hand-held probe integrated optical devices and US transducers. 3D volume data of the selected joint of each participant was collected using an automatic scanning device after the dual-modal imaging. The investigators plan to recruit RA patients from the outpatient department of Rheumatology of our hospital, who have been diagnosed as RA by experienced rheumatologists. The patients and healthy volunteers will receive multi-modal imaging examinations using the novel imaging system. The MCP 2 and 3, PIP 2 and 3, and wrist of bilateral hand were chosen for the multi-modal imaging. Conventional US scanning of the joints, including grey-scale US, CDUS, and PDUS, will be carried out by an experienced US operator. Afterwards, 2D and 3D PA/US imaging will be implemented for each joint by the same operator. All of the imaging data will be analysed by the Matlab software.
- Conditions
- Rheumatoid Arthritis, Ultrasonography
- Being tested
- Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
- Keywords
- rheumatoid arthritis, ultrasonography, multi-modal imaging, photoacoustic imaging
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemDiagnostic test
The multi-modal PA/US imaging system is equipped with a handheld 3D PA/US probe, and able to provide 3D volume data of dual-wavelength PA imaging of small joints, in addition to real-time 2D PA/US imaging.
| Study group | Role | What they receive |
|---|---|---|
| rheumatoid arthritis | The patients are diagnosed with RA according to the American College of Rheumatology (ACR) criteria, and the current clinical state was in-active or relapse. The patients receive final diagnosis and disease evaluation by two experienced rheumatologists Receives: Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The PA scores of 50 participants with RA identified by the multi-modal imaging system are in accordance with clinical scoring
A total of 50 participants received semi-quantitatively measurement of PA signals by the imaging system using a 0-3 scoring system. Score 0 is no PA signals, which represents no detectable active inflammation on PA imaging. Score 1 means less than 3 bars of PA signals within the inflamed regions. Score 2 means multiple PA signals within less than half of the inflammatory lesions. And score 3 means abundant PA signals in over half of the lesions of RA synovium or tenosynovium, which may represent high inflammation activity.
Measured: 3-6 months
The functional imaging of 60 RA patients assessed by the multi-modal imaging system
The oxgenation levels of local joint tissues of 60 RA patients are measured by dual-wavelength PA imaging.
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuxin Jiang, Doctor, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297475
- Sponsor's protocol ID
- MMPAUS RA
- Status last verified
- Sep 2020
- First submitted
- 13 Jul 2019
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang M, Zhao C, Wang M, Wang Q, Zhang R, Bai W, Liu J, Zhang S, Xu D, Liu S, Li X, Qi Z, Yang F, Zhu L, He X, Tian X, Zeng X, Li J, Jiang Y. Synovial Oxygenation at Photoacoustic Imaging to Assess Rheumatoid Arthritis Disease Activity. Radiology. 2023 Jan;306(1):220-228. doi: 10.1148/radiol.212257. Epub 2022 Aug 23.
PubMed 35997608
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Feasibility and Added Value of a Multi-modal Photoacoustic/Ultrasonic Imaging System in the Evaluation of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04297475
- Acronym / sponsor ID
- MMPAUS RA
- Conditions
- Rheumatoid Arthritis, Ultrasonography
- Keywords
- rheumatoid arthritis, ultrasonography, multi-modal imaging, photoacoustic imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New type of imaging method is in demand clinically for early detection and treatment guiding of RA. Photoacoustic imaging (PAI), a hot spot in medical imaging society, which combines the merits of optical imaging and US and has a capacity in morphological, functional and molecular imaging, has shown potential in visualizing superficial organs, including small joints. The investigators developed a multi-modal photoacoustic/ultrasound (PA/US) imaging system, equipped with a handheld 3D PA/US probe, which wass able to provide 3D volume data of dual-wavelength PA imaging of small joints, in addition to real-time 2D PA/US imaging. The investigators plan to recruit RA patients in different disease conditions and healthy volunteers to receive the 2D and 3D PA/US examination on the 2nd and 3rd MCP, PIP joints and wrist joints using this imaging system, and to evaluate the potential clinical role of the imaging system in RA, and its added value to current imaging methods.
Detailed description
The multi-modal PA/US imaging system was built on a high-end commercial US platform, and allowed real-time imaging of grey-scale US imaging, Color-Doppler US (CDUS) imaging and dual-wavelength PA imaging. The PA/US images were acquired using a hand-held probe integrated optical devices and US transducers. 3D volume data of the selected joint of each participant was collected using an automatic scanning device after the dual-modal imaging. The investigators plan to recruit RA patients from the outpatient department of Rheumatology of our hospital, who have been diagnosed as RA by experienced rheumatologists. The patients and healthy volunteers will receive multi-modal imaging examinations using the novel imaging system. The MCP 2 and 3, PIP 2 and 3, and wrist of bilateral hand were chosen for the multi-modal imaging. Conventional US scanning of the joints, including grey-scale US, CDUS, and PDUS, will be carried out by an experienced US operator. Afterwards, 2D and 3D PA/US imaging will be implemented for each joint by the same operator. All of the imaging data will be analysed by the Matlab software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis | – | Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemThe patients are diagnosed with RA according to the American College of Rheumatology (ACR) criteria, and the current clinical state was in-active or relapse. The patients receive final diagnosis and disease evaluation by two experienced rheumatologists |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The RA patients are diagnosed as RA by two experienced rheumatologists.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemThe multi-modal PA/US imaging system is equipped with a handheld 3D PA/US probe, and able to provide 3D volume data of dual-wavelength PA imaging of small joints, in addition to real-time 2D PA/US imaging. | Diagnostic test | rheumatoid arthritis |
Primary outcome
The PA scores of 50 participants with RA identified by the multi-modal imaging system are in accordance with clinical scoring
Time frame: 3-6 months
A total of 50 participants received semi-quantitatively measurement of PA signals by the imaging system using a 0-3 scoring system. Score 0 is no PA signals, which represents no detectable active inflammation on PA imaging. Score 1 means less than 3 bars of PA signals within the inflamed regions. Score 2 means multiple PA signals within less than half of the inflammatory lesions. And score 3 means abundant PA signals in over half of the lesions of RA synovium or tenosynovium, which may represent high inflammation activity.
The functional imaging of 60 RA patients assessed by the multi-modal imaging system
Time frame: 12-15 months
The oxgenation levels of local joint tissues of 60 RA patients are measured by dual-wavelength PA imaging.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Derived from this study: PubMed 35997608Yang M, Zhao C, Wang M, Wang Q, Zhang R, Bai W, Liu J, Zhang S, Xu D, Liu S, Li X, Qi Z, Yang F, Zhu L, He X, Tian X, Zeng X, Li J, Jiang Y. Synovial Oxygenation at Photoacoustic Imaging to Assess Rheumatoid Arthritis Disease Activity. Radiology. 2023 Jan;306(1):220-228. doi: 10.1148/radiol.212257. Epub 2022 Aug 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuxin Jiang, Doctor study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Yang, Doctor (8601060155494 ext. 8601060155494, yangmeng@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The PA scores of 50 participants with RA identified by the multi-modal imaging system are in accordance with clinical scoring (time frame: 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04297475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.