Synovitis and Therapy Response in Inflammatory Arthritis With Contrast Enhanced Ultrasound

NCT02902562 | Completed

• 1 other identifier: HS-15-00377
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Synovitis; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Kappa coefficient

  To assess the inter-reader agreement as well as the agreement between CEUS versus MRI determined treatment response.

  12 months

Study Arms (1)

Study Visit

OTHER

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); Procedure: Magnetic Resonance Imaging (MRI)

Interventions

Contrast Enhanced Ultrasound (CEUS) PROCEDURE

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

Study Visit

Magnetic Resonance Imaging (MRI) PROCEDURE

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.

Study Visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Wright Foundation: collaborator

Study Sites (1)

USC Department of Radiology

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Synovitis; Arthritis, Rheumatoid

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• George R Matcuk, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 16, 2016
• Study Start: August 31, 2016
• Primary Completion: July 17, 2018
• Study Completion: August 22, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)