Contrast-enhanced Bowel Ultrasound in Making a Diagnosis & Follow-up of

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03744130
Study type	Interventional
Source	State Scientific Centre of Coloproctology, Russian Federation
Contact	Larisa P Orlova, M.D.
Phone	+7 499 199 66 86
Email	lporlova2013@yandex.ru
Status	Recruiting
Phase	N/A
Start date	January 10, 2018
Completion date	June 30, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms