Ultrasound Evaluation of Crohn's Disease

Phase 4

Terminated

• Conditions: Crohn Disease
• Interventions: Drug: Sulfur Hexafluoride; Device: Ultrasound Elastography; Device: Ultrasound Vascularity; Device: Magnetic Resonance Enterography (MRE)

• Registration Number: NCT03235180
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2017-06-16
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-01
• Status Verified: 2021-10
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-12
• Results First Submitted: 2021-10-15
• Results First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Results First Posted: 2021-11-10
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Crohn's disease patients with involvement of terminal ileum (thickness > 3mm).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Crohn's Disease Subjects	Sulfur Hexafluoride	Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent. Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.
Crohn's Disease Subjects	Ultrasound Elastography	Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent. Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.
Crohn's Disease Subjects	Ultrasound Vascularity	Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent. Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.
Crohn's Disease Subjects	Magnetic Resonance Enterography (MRE)	Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent. Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.

Primary Outcome Measures

Name	Time	Method
Change in Shear Wave Speed	baseline, 6 months	Shear wave speed is a measure of small bowel stiffness; this will be measured on the General Electric (GE) Logiq E9 Ultrasound Scanner.
Change in Vessel Density	baseline, 6 months	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States