Contrast-Enhanced Ultrasound in Human Crohn's Disease

NCT02061163 | Withdrawn Phase 1 DMC

• 1 other identifier: HUM00080030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (1)

Subjects with Crohn's disease

EXPERIMENTAL

Contrast Enhanced Ultrasound Optison

Device: Contrast Enhanced Ultrasound; Drug: Optison

Interventions

Contrast Enhanced Ultrasound 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.

Subjects with Crohn's disease

Optison 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).

Subjects with Crohn's disease

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

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

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

FS 069

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 12, 2014
• Study Start: February 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: June 15, 2015

Record last verified: 2015-06

Locations

US (1)