MedTrace Logo

Non-invasive Imaging of GI Inflammation Using Microbubble Contrast Enhanced Ultrasonography

NCT00591669 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-04-26

No results posted yet for this study

Summary

Inflammatory bowel disease (IBD) is a common chronic inflammatory disorder, but a noninvasive method of assessing disease location, severity, and extent is currently not available. Recently published animal data suggests that using transabdominal ultrasound enhanced with encapsulated gaseous microbubbles may provide a reliable, noninvasive means to detect and quantify areas of intestinal inflammation. This study will evaluate the role of Contrast-enhanced ultrasonography (CEU) for use as a diagnostic tool in patients with IBD. We hypothesize that the severity and extent of chronic intestinal inflammation, as quantified by CEU-derived video intensity scores, will correlate with endoscopically-derived measures of intestinal inflammation as obtained from the Crohn's Disease Endoscopic Inflammatory Index (CDEIS). A total of 40 patients will be enrolled in the study, 30 patients with IBD and 10 patients undergoing colonoscopy for other reasons. Prior to colonoscopy CEU assessment of small and large intestine will be performed to evaluate neoangiogenesis and intestinal blood flow. The correlation between the CEU-derived video intensity score and CDEIS will be assessed using Pearson's correlation coefficient. Subjects may also undergo scoring using the Rutgeerts Score, an endoscopic disease assessment index used to score disease activity in patients with previous ileocolonic resection. Comparing video intensity between IBD and non-IBD subjects will be performed using the Wilcoxon rank sum test, with a secondary aim of establishing preliminary estimates of the sensitivity of the microbubble scoring system.

Conditions

Interventions

OTHER

Definity

We will be placing one vial (1.3) of Definity® in 50 mL of preservative-free saline. Our infusions will be initiated at slightly lower than recommended starting rate (3mL/min) and will be adjusted as necessary to produce optimal enhancement. The rate will not exceed 10 ml/min and we will not give more than 1.3 mL of Definity® in 50mL saline in any 24-hour period.

OTHER

Definity

We will be placing one vial (1.3) of Definity® in 50 mL of preservative-free saline. Our infusions will be initiated at slightly lower than recommended starting rate (3mL/min) and will be adjusted as necessary to produce optimal enhancement. The rate will not exceed 10 ml/min and we will not give more than 1.3 mL of Definity® in 50mL saline in any 24-hour period.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Brian Behm, MD · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00591669 on ClinicalTrials.gov