Ultrasound Evaluation of Crohn's Disease
Primary Purpose
Crohn Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sulfur Hexafluoride
Ultrasound Elastography
Ultrasound Vascularity
Magnetic Resonance Enterography (MRE)
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn Disease
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Crohn's Disease Subjects
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03235180
Brief Title
Ultrasound Evaluation of Crohn's Disease
Official Title
Ultrasound Evaluation of Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Unable to secure funding.
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crohn's Disease Subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sulfur Hexafluoride
Other Intervention Name(s)
Lumason
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound Elastography
Other Intervention Name(s)
GE Logiq E9 Ultrasound Scanner
Intervention Description
Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.
Intervention Type
Device
Intervention Name(s)
Ultrasound Vascularity
Other Intervention Name(s)
Verasonics
Intervention Description
Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Enterography (MRE)
Intervention Description
Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.
Primary Outcome Measure Information:
Title
Change in Shear Wave Speed
Description
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
Title
Change in Vessel Density
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigao Chen, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Ultrasound Evaluation of Crohn's Disease
We'll reach out to this number within 24 hrs