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

NCT00591669 | Terminated

• 1 other identifier: 11971
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Inflammatory Bowel Disease

Keywords

Inflammatory bowel disease; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• The primary study endpoint is to assess the degree of correlation of the video intensity score from microbubble imaging with an endoscopic scoring system for IBD, the Crohn's Disease Endoscopic Inflammatory Index (CDEIS).

  Following data collection

Secondary Outcomes (1)

• Secondary endpoint includes comparing the level of video intensity between 30 subjects with inflammatory bowel disease with 10 control patients who are undergoing endoscopic evaluation for non-inflammatory conditions of the large bowel.

  Following data collection

Study Arms (2)

1

EXPERIMENTAL

IBD patients

Other: Definity

2

OTHER

Control subjects

Other: Definity

Interventions

Definity OTHER

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.

1

Eligibility Criteria

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

You may qualify if:

• Patients with inflammatory bowel disease (IBD), scheduled for diagnostic colonoscopy or
• Patients scheduled for diagnostic colonoscopy for other indications other than IBD (e.g. screening, family history of colon cancer).

You may not qualify if:

• Ineligibility for colonoscopy
• For control patients: a personal history of IBD or clinical history suspicious for IBD or other disease associated with intestinal inflammation. To be determined by investigators at the time of screening.
• Abnormal QT, Tic, or PR intervals during screening ECG
• Life-threatening ventricular arrhythmias during screening ECG
• Abnormally low oxygen saturation (\<80%)
• History of the following:
• An intracardial or intrapulmonary shunt
• Unstable coronary artery disease
• Cerebrovascular disease (e.g. stroke or aneurysm)
• Diagnosed and or current signs or symptoms of severe, progressive or uncontrolled congenital heart failure
• Diagnosed and/or current signs or symptoms of severe, progressive or uncontrolled emphysema/COPD
• Diagnosed and/or current signs or symptoms of severe, progressive or uncontrolled pulmonary hypertension (known PA pressures \>50mmHg)
• Uncontrolled high blood pressure (\>140/90)
• Abnormal kidney function (creatinine \> 2.0 mg/dl or GFR \> 90)
• Abnormal liver function (Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase levels greater than 2 times the upper limit of normal.)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Interventions

perflutren

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Brian Behm, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: May 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 26, 2011

Record last verified: 2011-04

Locations

US (1)