Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00591669 · ClinicalTrials.gov registry record · NA
Non-invasive Imaging of GI Inflammation Using Microbubble Contrast Enhanced Ultrasonography
A NA study, sponsored by University of Virginia.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT00591669 is a NA study that was terminated before completion, run by University of Virginia. The registered enrollment target is 10 participants.
The verdict
NCT00591669, a NA study, was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
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.
Interventions
- OTHER Definity
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-05 |
| Est. Completion | 2010-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00591669
The ClinicalTrials.gov registry entry for NCT00591669 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Definity is the first listed.
NCT00591669 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00591669 about?
NCT00591669 is a clinical study titled "Non-invasive Imaging of GI Inflammation Using Microbubble Contrast Enhanced Ultrasonography". 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 microbu...
What is the current status of trial NCT00591669?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2006-05. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00591669?
The interventions under investigation include: Definity (OTHER).
Who is sponsoring clinical trial NCT00591669?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.