Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Disease
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Contrast-enhanced Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Disease focused on measuring Contrast-enhanced Ultrasound, Inflammatory Bowel Disease, CD, UC, SonoVue, Endoscopic activity
Eligibility Criteria
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
Sites / Locations
- State Scientific Centre of ColoproctologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
patients with UC
patients with CD
Arm Description
Patients with endoscopically proven UC with various extents of disease activity. Diagnostic Test: Contrast-enhanced Ultrasound
Patients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03744130
First Posted
November 14, 2018
Last Updated
November 20, 2018
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT03744130
Brief Title
Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
Official Title
Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Contrast-enhanced Ultrasound, Inflammatory Bowel Disease, CD, UC, SonoVue, Endoscopic activity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with UC
Arm Type
Experimental
Arm Description
Patients with endoscopically proven UC with various extents of disease activity.
Diagnostic Test: Contrast-enhanced Ultrasound
Arm Title
patients with CD
Arm Type
Experimental
Arm Description
Patients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound
Intervention Type
Diagnostic Test
Intervention Name(s)
Contrast-enhanced Ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Correlation between contrast-enhanced ultrasound time-intensity curves and endoscopic disease activity
Description
Particular time-intensity curve characteristics (AUC, Peak intensity etc.) could correlate with endoscopic activity of ulcerative colitis
Time Frame
[7 days]
Secondary Outcome Measure Information:
Title
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
Description
Particular time-intensity curve characteristics could correlate with grade of fibrosis in the resected bowel segment
Time Frame
[14 days]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Larisa P Orlova, M.D.
Phone
+7 499 199 66 86
Email
lporlova2013@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larisa P Orlova, M.D.
Organizational Affiliation
State Scientific Centre of Coloproctology, Russian Federation
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Scientific Centre of Coloproctology
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larisa P Orlova, M.D.
Phone
+7 499 199 66 86
Email
lporlova2013@yandex.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
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