Contrast-Enhanced Ultrasound in Human Crohn's Disease

NCT ID: NCT02061163

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-01-31

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Subjects with Crohn's disease

Contrast Enhanced Ultrasound Optison

Group Type: EXPERIMENTAL

Contrast Enhanced Ultrasound

Intervention Type: DEVICE

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

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jonathan R. Dillman M.D.

Assistant Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00080030

Identifier Type: -

Identifier Source: org_study_id