Contrast-Enhanced Ultrasound in Human Crohn's Disease



Status:Not yet recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:10 - Any
Updated:7/11/2015
Start Date:February 2015
End Date:January 2018
Contact:Jonathan Dillman, MD
Email:jonadill@med.umich.edu
Phone:734-232-9247

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Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease

To determine if contrast enhanced ultrasound (CEUS) and shear wave elastography can
accurately diagnose bowel wall inflammation and fibrosis in patients with known Crohn's
disease.

Crohn's disease (CD) is an inflammatory condition that affects the intestinal tract (large
and small bowels). Some patients with CD may get swelling of the intestinal tract
(inflammation) or scarring of the intestinal tract (fibrosis). Fibrosis develops because of
chronic injury. Both inflammation (swelling) and fibrosis (scarring) can cause the bowel to
narrow, which can lead to the bowel becoming blocked. The long-term goal of this project is
to develop new noninvasive radiology imaging tests that can show the difference between
bowel wall inflammation and fibrosis. Currently there are no imaging tests that can do this
reliably.

Current imaging methods (CT and MRI) that are ordered to help diagnose and follow-up CD are
excellent at showing inflammation, but are not accurate for finding fibrosis. CT also
exposes patients to small amounts of radiation, and both CT and MRI are costly. We are
therefore studying ultrasound imaging, as it is more cost-effective and does not expose
patients to radiation. CEUS uses microbubbles in a solution that are injected into a vein
in one of the arms. This allows doctors to see the blood flow to parts of the body. This
microbubble contrast agent (dye) is called Optison. Another imaging method, called shear
wave elastography, uses sound waves to noninvasively measure the stiffness of structures in
the body.

It is important to be able to tell the difference between inflammation and fibrosis in
Crohn's disease, because narrowing of the bowel due to inflammation generally responds well
to medications, whereas narrowing caused by fibrosis does not respond well to medications
and may require surgery.

Inclusion Criteria:

- Patients 10 years of age and older

- Have been diagnosed with small bowel Crohn's disease

- Are receiving medical therapy for Crohn's disease

- Are scheduled for surgery (bowel resection) OR

- Are scheduled for a clinically-indicated MR enterography (MRE)/MRI exam.

Exclusion Criteria:

- Patients under the age of 10

- Are pregnant or breast feeding

- Are significantly overweight - BMI >35-40

- Have an inability to understand the consent

- Have prior allergic-like reaction or other adverse reaction to microbubble contrast
agent

- Hypersensitivity to perflutren, blood, blood products or albumen

- Have a cardiac shunt

- Known unstable cardiac condition such as history of a heart attach, irregular
heartbeat, congestive heart failure, etc.

- Known acute or chronic kidney disease, moderate/severe lung disease or acute or
chronic liver disease
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