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

October 26, 2020 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Meng Yang, Doctor
        • Sub-Investigator:
          • Chenyang Zhao, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3-6 months
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.
12-15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yuxin Jiang, Doctor, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MMPAUS RA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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