Ultrasound Evaluation of Crohn's Disease

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

Study Overview

• Status: Terminated
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Sulfur Hexafluoride; Device: Ultrasound Elastography; Device: Ultrasound Vascularity; Device: Magnetic Resonance Enterography (MRE)

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Crohn's Disease Subjects; 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.

Drug: Sulfur Hexafluoride; 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.; Other Names: Lumason; Device: Ultrasound Elastography; Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.; Other Names: GE Logiq E9 Ultrasound Scanner; Device: Ultrasound Vascularity; Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.; Other Names: Verasonics; Device: Magnetic Resonance Enterography (MRE); Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	baseline, 6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Shigao Chen, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): October 12, 2021
• Study Completion (Actual): October 12, 2021

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 17-001175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No