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

Rheumatoid Arthritis Clinical Trial

Official title:

The Clinical Feasibility and Added Value of a Multi-modal Photoacoustic/Ultrasonic Imaging System in the Evaluation of Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297475
• Other study ID #: MMPAUS RA
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2020
• Source: Peking Union Medical College Hospital
• Contact: Meng Yang, Doctor
• Phone: 8601060155494
• Email: yangmeng[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

The inclusion criteria

1. The patients were above 18 years-old;

2. 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;

3. The patients were consent to receive examinations of photoacoustic imaging.

The exclusion criteria

1. The patients had mental disease or other severe diseases, and were not capable of receiving imaging examinations;

2. The patients had strong reaction to laser light.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Ultrasonography

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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