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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Recruitment Status : Withdrawn (PI leaving UM at the end of the month)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
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Device: Contrast Enhanced Ultrasound Drug: Optison Phase 1 Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: Optison
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).




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Michigan
University of Michigan C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan

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Responsible Party: Jonathan R. Dillman M.D., Assistant Professor of Radiology, University of Michigan
ClinicalTrials.gov Identifier: NCT02061163     History of Changes
Other Study ID Numbers: HUM00080030
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases