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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Diagnostic test: Contrast-enhanced Ultrasound

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larisa P Orlova, M.D.; Phone Number: +7 499 199 66 86; Email: lporlova2013@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 123423
    • Recruiting
    • State Scientific Centre of Coloproctology
    • Contact: Larisa P Orlova, M.D.; Phone Number: +7 499 199 66 86; Email: lporlova2013@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with UC; Patients with endoscopically proven UC with various extents of disease activity. Diagnostic Test: Contrast-enhanced Ultrasound	Diagnostic test: Contrast-enhanced Ultrasound; 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
Experimental: patients with CD; Patients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound	Diagnostic test: Contrast-enhanced Ultrasound; 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

What is the study measuring?

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]

Collaborators and Investigators

• Sponsor: State Scientific Centre of Coloproctology, Russian Federation
• Investigators: Principal Investigator: Larisa P Orlova, M.D., State Scientific Centre of Coloproctology, Russian Federation

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; CD; UC; SonoVue; Contrast-enhanced Ultrasound; Endoscopic activity
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 34A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No