Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of SonoVue® in participants with Crohn's disease and ulcerative colitis to various aspects including type of Inflammatory Bowel Disease, disease activity, the need for surgical treatment.

Detailed Description
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Each patient is subjected to clinical, laboratory and endoscopic evaluation, each eligible patient is assigned to one of the arms: Arm 1: patients with ulcerative colitis (50 patients) Arm 2: patients with Crohn's disease (50 patients) In each arm, patients are classified according to clinical an endoscopic activity of the disease. Each patient is subjected to ultrasound examination of the bowel using a Philips iU 22 machine according to a standardized protocol: 12h fasting period exploratory scanning with the use of convex C5-1 probe detailed scanning with the use of linear L 12-5 probe with Power Doppler choosing a bowel segment with the most prominent changes Contrast-enhanced Ultrasound (CEUS) CEUS is performed according to the following protocol: administration of drotaverine hydrochloride (No-Spa ®) to reduse excessive peristaltic movement visualization of the previously chosen affected bowel segment with the use of DCE-US (Dynamic Contrast-Enhanced Ultrasound) technology administration of 2.4 ml SonoVue® intravenously with a bolus injection through a peripheric venous line (left antecubital vein), followed by a 10ml 0.9% Natrium Chloride bolus the video-loop is acquired during contrast agent administration and wash-out (preferable loop duration - 3 min) the original DICOM loop is sent to a work station Philips QLab platform is used to acquire a fitted Local Density Random Walk Wash-in Wash-out algorithm (LDRWIWO algorhithm) time-intensity curve of contrast agent wash-in and wash-out. Qualitative and quantitative (Time to peak, Rise time, Mean transit time, Wash-in Slope, Peak intensity, Area under curve, Time from peak to one half) parameters are calculated for each region of interest (ROI).

Official Title
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Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Diagnostic Test: Contrast-enhanced Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with verified UC/CD aged from 18 to 60y signed informed consent form for the study Exclusion Criteria: pregnancy known allergy or history of adverse reaction to sulfur hexafluoride preparations marked pulmonary hypertension uncontrolled hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with UC<br>Patients with endoscopically proven UC with various extents of disease activity. Diagnostic Test: Contrast-enhanced Ultrasound | Diagnostic Test: Contrast-enhanced Ultrasound<br>* administration of drotaverine hydrochloride (No-Spa ®) to reduse excessive peristaltic movement visualization of the previously chosen affected bowel segment with the use of DCE-US (Dynamic Contrast-Enhanced Ultrasound) technology administration of 2.4 ml SonoVue® intravenously with a bolus injection through a peripheric venous line (left antecubital vein), followed by a 10ml 0.9% Natrium Chloride bolus the video-loop is acquired during contrast agent administration and wash-out (preferable loop duration - 3 min) the original DICOM loop is sent to a work station<br>|
| Experimental: patients with CD<br>Patients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound | Diagnostic Test: Contrast-enhanced Ultrasound<br>* administration of drotaverine hydrochloride (No-Spa ®) to reduse excessive peristaltic movement visualization of the previously chosen affected bowel segment with the use of DCE-US (Dynamic Contrast-Enhanced Ultrasound) technology administration of 2.4 ml SonoVue® intravenously with a bolus injection through a peripheric venous line (left antecubital vein), followed by a 10ml 0.9% Natrium Chloride bolus the video-loop is acquired during contrast agent administration and wash-out (preferable loop duration - 3 min) the original DICOM loop is sent to a work station<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between contrast-enhanced ultrasound time-intensity curves and endoscopic disease activity | Particular time-intensity curve characteristics (AUC, Peak intensity etc.) could correlate with endoscopic activity of ulcerative colitis | [7 days] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between contrast-enhanced ultrasound time-intensity curves in patients with Crohn disease and fibrosis grade according to morphologic analysis of the resected bowel segment | Particular time-intensity curve characteristics could correlate with grade of fibrosis in the resected bowel segment | [14 days] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast-enhanced Ultrasound, Inflammatory Bowel Disease, CD, UC, SonoVue, Endoscopic activity