Contrast-Enhanced Ultrasound in Human Crohn's Disease

University of Michigan

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Crohn's Disease

Treatments

Drug: Optison

Device: Contrast Enhanced Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT02061163

HUM00080030

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

10+ years old

Volunteers

No 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