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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Recruitment Status : Withdrawn (PI leaving UM at the end of the month)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

Tracking Information
First Submitted Date  ICMJE February 6, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date June 15, 2015
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contrast-Enhanced Ultrasound in Human Crohn's Disease
Official Title  ICMJE Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • 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).
Study Arms  ICMJE Experimental: Subjects with Crohn's disease
Contrast Enhanced Ultrasound Optison
Interventions:
  • Device: Contrast Enhanced Ultrasound
  • Drug: Optison
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 12, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
84
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061163
Other Study ID Numbers  ICMJE HUM00080030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan R. Dillman M.D., University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP