Contrast-Enhanced Ultrasound in Human Crohn's Disease

Sponsor

University of Michigan (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02061163

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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 :

Feb 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Evaluation of bowel wall inflammation and fibrosis in patients with Crohn's disease using CEUS [2 years]
CEUS will be performed to evaluate inflammation and fibrosis in patients with Crohn's disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan C.S. Mott Children's Hospital	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan R. Dillman M.D., Assistant Professor of Radiology, University of Michigan

ClinicalTrials.gov Identifier:

NCT02061163

Other Study ID Numbers:

HUM00080030

First Posted:

Feb 12, 2014

Last Update Posted:

Jun 15, 2015

Last Verified:

Jun 1, 2015

Additional relevant MeSH terms:

Crohn Disease

Study Results

No Results Posted as of Jun 15, 2015