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Contrast-Enhanced Ultrasound in Human Crohn's Disease

NCT02061163 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2015-06-15

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061163 on ClinicalTrials.gov