A Phase 1/2 interventional study of Contrast Enhanced Ultrasound and Optison in Crohn's Disease, sponsored by University of Michigan. Withdrawn at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2015-06-15.
Sponsored by University of Michigan · Phase 1/2, Interventional, and Diagnostic
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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Contrast Enhanced Ultrasound Optison
Device: Contrast Enhanced Ultrasound · Drug: Optison
Subjects with Crohn's disease will undergo contrast enhanced ultrasound imaging with shear wave elastography. Both CEUS and shear wave elastography will be performed using FDA approved ultrasound machines.
Optison is a microbubble contrast agent (dye) that will be injected during the CEUS imaging. Optison is FDA-approved for use in heart ultrasounds but not approved for use in bowel ultrasounds. Its use in this study is considered investigational (off-label).
Evaluation of bowel wall inflammation and fibrosis in patients with Crohn's disease using CEUS
CEUS will be performed to evaluate inflammation and fibrosis in patients with Crohn's disease
Time frame: 2 years
This study is withdrawn, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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