Ultrasound Evaluation of Crohn's Disease

Phase 4TerminatedNCT03235180

Mayo Clinic9 enrolled

Overview

The purpose of this study is to assess the effectiveness of a new ultrasound technology for evaluating Crohn's disease.

The investigators will study the efficacy of ultrasound shear wave elastography and vascularity imaging for Crohn's Disease (CD) evaluation. Literature evidences demonstrate that bowel stiffness is correlated with fibrosis, while bowel vascularity and perfusion is correlated with inflammation. Therefore, the investigators expect the combination of shear wave elastography and vascularity imaging can increase the sensitivity and specificity of CD evaluation. Ultrasound is safe, cost-effective, and widely accessible, thus provides an attractive alternative to the clinical standard Computed Tomography (CT), risks of radiation)) and Magnetic Resonance Imaging (MRI), more expensive and limited accessibility)). Because ultrasound may not be able to image bowel loops deep in the body, its main role is for follow-up after initial screening by CT or MRI, especially for terminal ileum, which is easily accessible by ultrasound and the most frequently affected bowel segment for CD.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Crohn Disease

Interventions

Sulfur HexafluorideDRUG

Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.

Ultrasound ElastographyDEVICE

Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.

Ultrasound VascularityDEVICE

Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Crohn's disease patients with involvement of terminal ileum (thickness \> 3mm). Exclusion Criteria: * Patients with change of medicine or going to surgery over the 6-months follow-up period. * Patients with unreliable ultrasound images due to conditions such as large body habitus or poor ultrasound imaging window. * Adults lacking capacity to consent. * Vulnerable subjects such as prisoners. * Pregnant women and nursing mothers. * Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts. * Patients with history of hypersensitivity allergic reactions to ultrasound contrast agents.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Shear Wave Speed

Shear wave speed is a measure of small bowel stiffness; this will be measured on the General Electric (GE) Logiq E9 Ultrasound Scanner.

Time frame: baseline, 6 months

Change in Vessel Density

Vessel density is a measure of the vascularity of the bowel. It is the percentage of pixels in the bowel lesion with blood flow compared to the total area of the lesion. This will be measured with the Verasonics Ultrasound Scanner.

Time frame: baseline, 6 months

Data from ClinicalTrials.gov

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