Ultrasound Evaluation of Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Ultrasound Evaluation of Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03235180
• Other study ID #: 17-001175
• Status: Terminated
• Phase: Phase 4
• Start date: June 16, 2017
• Est. completion date: October 12, 2021

Study information

• Verified date: October 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.

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.
• Ultrasound Vascularity
Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.
• Magnetic Resonance Enterography (MRE)
Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials