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

Primary Purpose

Synovitis, Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contrast Enhanced Ultrasound (CEUS)
Magnetic Resonance Imaging (MRI)
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Synovitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC Department of Radiology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Visit

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2016
Last Updated
April 15, 2019
Sponsor
University of Southern California
Collaborators
Wright Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02902562
Brief Title
Synovitis and Therapy Response in Inflammatory Arthritis With Contrast Enhanced Ultrasound
Acronym
CEUS
Official Title
Quantitative Assessment of Synovitis and Therapy Response in Inflammatory Arthritis With Contrast Enhanced Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 31, 2016 (Actual)
Primary Completion Date
July 17, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Wright Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Synovitis, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Visit
Arm Type
Other
Arm Description
You will have a Contrast Enhanced Ultrasound (CEUS) and contrast Magnetic Resonance Imaging (MRI) which will take about 2 hours.
Intervention Type
Procedure
Intervention Name(s)
Contrast Enhanced Ultrasound (CEUS)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kappa coefficient
Description
To assess the inter-reader agreement as well as the agreement between CEUS versus MRI determined treatment response.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George R Matcuk, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Department of Radiology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Synovitis and Therapy Response in Inflammatory Arthritis With Contrast Enhanced Ultrasound

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