Crohn Disease
Conditions
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.
Interventions
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.
DEVICEUltrasound Elastography
Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.
DEVICEUltrasound Vascularity
Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.
Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
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. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Crohn's Disease Subjects |
|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 15.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease Subjects | Change in Shear Wave Speed | 8.42 KPa | Standard Deviation 4.07 |
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.
Time frame: baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease Subjects | Change in Vessel Density | 14.1 percentage of pixels | Standard Deviation 6.18 |