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

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03744130
• Other study ID #: 34A
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2018
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: Larisa P Orlova, M.D.
• Phone: +7 499 199 66 86
• Email: lporlova2013[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]