Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2018
CompletedFirst Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedNovember 23, 2018
November 1, 2018
3 years
November 14, 2018
November 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
[14 days]
Study Arms (2)
patients with UC
EXPERIMENTALPatients with endoscopically proven UC with various extents of disease activity. Diagnostic Test: Contrast-enhanced Ultrasound
patients with CD
EXPERIMENTALPatients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound
Interventions
1. administration of drotaverine hydrochloride (No-Spa ®) to reduse excessive peristaltic movement 2. visualization of the previously chosen affected bowel segment with the use of DCE-US (Dynamic Contrast-Enhanced Ultrasound) technology 3. 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 4. the video-loop is acquired during contrast agent administration and wash-out (preferable loop duration - 3 min) 5. the original DICOM loop is sent to a work station
Eligibility Criteria
You may qualify if:
- patient with verified UC/CD aged from 18 to 60y
- signed informed consent form for the study
You may not qualify if:
- pregnancy
- known allergy or history of adverse reaction to sulfur hexafluoride preparations
- marked pulmonary hypertension
- uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Scientific Centre of Coloproctology
Moscow, 123423, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Larisa P Orlova, M.D.
State Scientific Centre of Coloproctology, Russian Federation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2018
First Posted
November 16, 2018
Study Start
January 10, 2018
Primary Completion
December 30, 2020
Study Completion
June 30, 2021
Last Updated
November 23, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share