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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: Clinical Trial NA study, sponsored by University of Virginia.
NCT00591669 is a NA study that was terminated before completion, run by University of Virginia. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00591669 stopped before completion
NCT00591669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Definity is the first listed.
NCT00591669 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00591669's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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