The Clinical Feasibilityof a Multi-modal Photoacoustic/Ultrasonic Imaging System in Rheumatoid Arthritis

NCT04297475 | Unknown

• 1 other identifier: MMPAUS RA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Rheumatoid Arthritis; Ultrasonography

Keywords

rheumatoid arthritis; ultrasonography; multi-modal imaging; photoacoustic imaging

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12-15 months

Study Arms (1)

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

Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system

Interventions

Multi-modal photoacoustic/ultrasonic (PA/US) imaging system DIAGNOSTIC_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.

rheumatoid arthritis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The RA patients are diagnosed as RA by two experienced rheumatologists.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35997608 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yuxin Jiang, Doctor

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Meng Yang, Doctor

CONTACT

8601060155494; yangmeng@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: March 5, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: October 28, 2020

Record last verified: 2020-09

Locations

CN (1)