Contrast-Enhanced Ultrasound in Human Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT02061163|
Recruitment Status : Withdrawn (PI leaving UM at the end of the month)
First Posted : February 12, 2014
Last Update Posted : June 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Device: Contrast Enhanced Ultrasound Drug: Optison||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2018|
Experimental: Subjects with Crohn's disease
Contrast Enhanced Ultrasound Optison
Device: Contrast Enhanced Ultrasound
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 [ Time Frame: 2 years ]CEUS will be performed to evaluate inflammation and fibrosis in patients with Crohn's disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061163
|United States, Michigan|
|University of Michigan C.S. Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|