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临床试验/NCT02902562
NCT02902562已完成不适用

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

University of Southern California2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Kappa coefficient

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

Study Visit

Other

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

干预措施: Contrast Enhanced Ultrasound (CEUS) (Procedure)

Study Visit

Other

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

干预措施: Magnetic Resonance Imaging (MRI) (Procedure)

结局指标

主要结局

Kappa coefficient

时间窗: 12 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

George Matcuk

Associate Professor

University of Southern California

研究点 (2)

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