Inflammatory Bowel DiseaseNCT03744130
Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
A study testing Contrast-enhanced Ultrasound in people with Inflammatory Bowel Disease, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Contrast-enhanced Ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jan 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient with verified UC/CD aged from 18 to 60y
- signed informed consent form for the study
Who cannot join
- pregnancy
- known allergy or history of adverse reaction to sulfur hexafluoride preparations
- marked pulmonary hypertension
- uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Scientific Centre of Coloproctology
Moscow, 123423
Larisa P Orlova, M.D., +7 499 199 66 86, lporlova2013@yandex.ru
About this study
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.
Read the 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).
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Contrast-enhanced Ultrasound
- Keywords
- Contrast-enhanced Ultrasound, Inflammatory Bowel Disease, CD, UC, SonoVue, Endoscopic activity
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced UltrasoundDiagnostic test
- 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
| Study group | Role | What they receive |
|---|---|---|
| patients with UC | Experimental | Patients with endoscopically proven UC with various extents of disease activity.
Diagnostic Test: Contrast-enhanced Ultrasound Receives: Diagnostic Test: Contrast-enhanced Ultrasound |
| patients with CD | Experimental | Patients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound Receives: Diagnostic Test: Contrast-enhanced Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [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
Particular time-intensity curve characteristics could correlate with grade of fibrosis in the resected bowel segment
Measured: [14 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start10 Jan 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Larisa P Orlova, M.D., Principal investigator, State Scientific Centre of Coloproctology, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744130
- Sponsor's protocol ID
- 34A
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03744130
- Acronym / sponsor ID
- 34A
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Contrast-enhanced Ultrasound, Inflammatory Bowel Disease, CD, UC, SonoVue, Endoscopic activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with UC | Experimental | Diagnostic Test: Contrast-enhanced UltrasoundPatients with endoscopically proven UC with various extents of disease activity. Diagnostic Test: Contrast-enhanced Ultrasound |
| patients with CD | Experimental | Diagnostic Test: Contrast-enhanced UltrasoundPatients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patient with verified UC/CD aged from 18 to 60y
- signed informed consent form for the study
Key exclusion criteria (4 listed)
- pregnancy
- known allergy or history of adverse reaction to sulfur hexafluoride preparations
- marked pulmonary hypertension
- uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced Ultrasound1. 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 | Diagnostic test | patients with CD, patients with UC |
Primary outcome
Correlation between contrast-enhanced ultrasound time-intensity curves and endoscopic disease activity
Time frame: [7 days]
Particular time-intensity curve characteristics (AUC, Peak intensity etc.) could correlate with endoscopic activity of ulcerative colitis
1 secondary outcome
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
Time frame: [14 days]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa P Orlova, M.D. principal investigator
State Scientific Centre of Coloproctology, Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced Ultrasound in people with Inflammatory Bowel Disease, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Larisa P Orlova, M.D. (+7 499 199 66 86, lporlova2013@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between contrast-enhanced ultrasound time-intensity curves and endoscopic disease activity (time frame: [7 days]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.