Non-invasive Imaging of GI Inflammation Using Microbubble Contrast Enhanced Ultrasonography
Stopped early · Not applicable
Conditions studied: Inflammatory Bowel Disease
In brief
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.
Key facts
- Study ID
- NCT00591669
- Run by
- University of Virginia
- People needed
- 10
- Starts
- 2006-05-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2011-04-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.)
- Known hypersensitivity to octafluoropropane
- Pregnancy or nursing, confirmed by urine pregnancy test.
Where it is running
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.