Crohn's Disease Clinical Trial
Official title:
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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