Contrast-Enhanced Ultrasound in Human Crohn's Disease

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan

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