Synovitis and Therapy Response in Inflammatory Arthritis With Contrast Enhanced Ultrasound (CEUS)

Quantitative Assessment of Synovitis and Therapy Response in Inflammatory Arthritis With Contrast Enhanced Ultrasound

This study is about using contrast-enhanced ultrasound (CEUS) to assess the degree of synovitis (joint inflammation) in patients with inflammatory arthritis, such as rheumatoid arthritis, and whether it can be used for assessing a treatment response. The investigators hope to learn whether contrast enhanced ultrasounds are better than regular imaging techniques, such as MRI, when used to evaluate the response to disease modifying anti-rheumatic drug (DMARD) therapy in inflammatory arthritis.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Synovitis
• Intervention / Treatment: Procedure: Contrast Enhanced Ultrasound (CEUS); Procedure: Magnetic Resonance Imaging (MRI)

Detailed Description

Inflammatory arthritis affects approximately 1% of the world population and can lead to significant pain and disability. Although radiographs can identify characteristic patterns of joint space narrowing and erosive changes, these findings are typically late findings and represent irreversible damage. With the development of disease modifying anti-rheumatic drugs (DMARDs), the goal is now to identify the pre-erosive inflammatory features and identify the patients that progress further into severe functional debility if not treated immediately.

MRI with gadolinium enhancement is proven to be very effective in early detection of soft tissue, bone erosions, synovitis, the integrity of ligaments, cartilage and bone marrow edema. However, MRI is expensive, may be impractical for assessing multiple joints and has relatively long examination time. Some patients may have claustrophobia and some may have contraindications to gadolinium administration. The investigators overarching goal is to determine whether the perfusion information provided by novel ultrasound based techniques such as, contrast enhanced ultrasound and superb microvascular imaging, can be used for assessment of treatment response to DMARD therapy for inflammatory arthritis. The recent advances in evaluation of vascularity of the tumors using contrast ultrasound technique can also be applied to rheumatological diseases. It is ideal to develop a sensitive imaging technique that can be routinely available and is relatively cheap. Ultrasound is available and has low cost and can be used for assessment of treatment response to DMARD therapy

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Department of Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients (≥ 18 years of age) that meet diagnostic criteria for an inflammatory arthritis.
• Clinical suspicion of active synovitis involving at least one target joint.
• Patients competent to sign study specific Informed Consent.
• Patients willing to comply with protocol requirements.
• Intent to treat with disease-modifying anti-rheumatic drugs (DMARDs).

Exclusion Criteria:

• Patients who are pregnant or less than 18 years of age.
• Patients who have a known cardiac shunt or pulmonary hypertension.
• Patients with any known hypersensitivity to perflutren or gadolinium contrast agents or renal insufficiency (GFR < 30 mL/min).
• Patients who cannot consent for themselves.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Study Visit; You will have a Contrast Enhanced Ultrasound (CEUS) and contrast Magnetic Resonance Imaging (MRI) which will take about 2 hours.

Procedure: Contrast Enhanced Ultrasound (CEUS); An intravenous line (IV) line will be inserted into a vein in your arm. You will be asked to lie on a table for the ultrasound imaging. First, a regular ultrasound (without contrast) will be performed and the images will be recorded. For the contrast enhanced ultrasound, the contrast agent will be injected into your IV line. We will perform another ultrasound and the images will be recorded; Procedure: Magnetic Resonance Imaging (MRI); For the contrast MRI, the contrast agent will be injected into your IV line The MRI scanner is a small, tunnel-like machine in which a patient will be required to lie still for a long period of time. There is little space inside the scanner, which causes anxiety and discomfort for patients who fear enclosed spaces. A technician will be present at all times during the examination to communicate with you about how you are feeling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kappa coefficient	To assess the inter-reader agreement as well as the agreement between CEUS versus MRI determined treatment response.	12 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Wright Foundation
• Investigators: Principal Investigator: George R Matcuk, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2016
• Primary Completion (ACTUAL): July 17, 2018
• Study Completion (ACTUAL): August 22, 2018

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (ESTIMATE): September 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Synovitis
• Other Study ID Numbers: HS-15-00377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED