Contrast-Enhanced Ultrasound in Human Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Contrast Enhanced Ultrasound
Optison
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn's Disease
Eligibility 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
Sites / Locations
- University of Michigan C.S. Mott Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with Crohn's disease
Arm Description
Contrast Enhanced Ultrasound Optison
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02061163
Brief Title
Contrast-Enhanced Ultrasound in Human Crohn's Disease
Official Title
Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI leaving UM at the end of the month
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with Crohn's disease
Arm Type
Experimental
Arm Description
Contrast Enhanced Ultrasound Optison
Intervention Type
Device
Intervention Name(s)
Contrast Enhanced Ultrasound
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Optison
Intervention Description
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 Measure Information:
Title
Evaluation of bowel wall inflammation and fibrosis in patients with Crohn's disease using CEUS
Description
CEUS will be performed to evaluate inflammation and fibrosis in patients with Crohn's disease
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Michigan C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Contrast-Enhanced Ultrasound in Human Crohn's Disease
We'll reach out to this number within 24 hrs