- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03435016
A Comparative Study of MRI, US and CE for Assessing Treatment Response in Known Crohn's Disease
A Comparative Study of Magnetic Resonance Imaging, Ultrasound and Capsule Endoscopy of the Small and Large Intestine for Assessing Treatment Response in Known Crohn's Disease
The aim of this study is to evaluate non-invasive imaging techniques for assessing treatment response in known Crohn's disease.
Comparing imaging modalities:
The applicability of small bowel colon capsule endoscopy (SBCCE), magnetic resonance enterocolonography (MREC) and ultrasound (US) for diagnosing ulcer healing after medical treatment in patients with symptomatic Crohn's disease compared to ileocolonoscopy.
- Sensitivity and specificity for ulcer healing
- Changes in activity parameters for SBCCE, MREC and US before and after medical treatment.
- Feasibility of SBCCE, MREC and US for assessing treatment response in known Crohn's disease.
Treatment induced bowel wall alterations visualized with ultrasound:
- A non-blinded study of bowel wall changes detected with repeated US examination during medical treatment of known Crohn's disease.
- Changes in bowel wall thickness, vascularity and elastography parameters, and time to normalization of the bowel wall.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to evaluate the applicability of SBCCE, MREC and US for diagnosing ulcer healing after medical treatment in patients with symptomatic CD compared to the current gold standard (ileocolonoscopy).
This is a prospective, blinded, multicenter study. Patients are recruited from 3 centers in the Region of Southern Denmark managing adult patients with inflammatory bowel diseases. Each patient goes through a standardized work-up including medical history, physical examination, C-reactive protein, fecal calprotectin, ileocolonoscopy, SBCCE, MREC and US before and 10-12 weeks after medical treatment with corticosteroids or biological therapy (Infliximab, Adalimumab, Vedolizumab or Ustekinumab). All examinations are reviewed and described in a standardized fashion. The radiologists and physicians describing SBCCE, MREC, and US are blinded to the findings at ileocolonoscopy and the other imaging modalities. Ileocolonoscopy serves as the diagnostic gold standard, and endoscopic disease activity is assessed with SES-CD.
LOGISTICS: Patients go through an accelerated diagnostic work-up at inclusion and after 10-12 weeks of medical treatment. In patients undergoing their first diagnostic work-up, ileocolonoscopy with biopsies is performed last to avoid false positive lesions at SBCCE. In patients with an established diagnosis, examinations can be performed in a random order provided that tissue samples are not taken during ileocolonoscopy. All diagnostic procedures should be completed within two weeks. If one imaging modality is contraindicated it is classified as "not performed". If ileocolonoscopy (gold standard) is contraindicated, the patient is excluded from the study. All radiological examinations are performed in the Department of Radiology, Lillebaelt Hospital Vejle. Ileocolonoscopy and SBCCE are performed at the local gastroenterology department.
During the pre- and post-treatment assessment, radiological examinations and SBCCE are analyzed by physicians blinded to the result of ileocolonoscopy and the other bowel examinations. However, at the post-treatment assessment, physicians are not blinded to the pre-treatment examinations. After completing all diagnostic procedures, the treating gastroenterologist is provided with the results of SBCCE, MREC and US.
EXTENDED ULTRASOUND STUDY: Patients are scheduled for additional US procedures after 2 and 4 weeks. Procedures are performed without blinding, i.e. the physician is aware of the results of the pre-treatment assessment and the preceding US examinations. If the bowel wall normalizes at week 2, the subsequent procedure is cancelled. Fecal calprotectin is measured before each US procedure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael D Jensen, MD, PhD
- Phone Number: 0045 7940 6345
- Email: michael.dam.jensen@rsyd.dk
Study Contact Backup
- Name: Mie A Juel, MD
- Phone Number: 0045 7940 6345
- Email: mie.agerbaek.juel@rsyd.dk
Study Locations
-
-
-
Vejle, Denmark, 7100
- Sygehus Lillebaelt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- An established diagnosis of CD
- Age > 18 years
- Ileocolonoscopy: Endoscopically active CD (SES-CD ≥ 3)
- Clinically active CD (Harvey-Bradshaw Index ≥ 5 or Crohn's Disease Activity Index ≥ 150)
- Clinical indication for medical treatment with corticosteroids or biological therapy
- Signed informed consent
Exclusion Criteria:
- Acute bowel obstruction
- Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion except prophylactic treatment with low dose Aspirin (≤ 150 mg per day)
- Pregnancy or lactation
- Alcohol or drug abuse
- Known gastrointestinal disorder other than inflammatory bowel disease
- Renal failure defined by a plasma-creatinine above the normal reference range
- Claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes MREC
- Interpreter required or inability to understand the oral and written information
- Bowel surgery performed between pre- and post-treatment assessment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Diagnosis
|
Patients are examined with all modalities.
MR enterocolonography, ultrasound, and small bowel capsule endoscopy are compared against ileocolonoscopy (gold standard).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy
Time Frame: 8-10 weeks
|
Sensitivity and specificity of SBCCE, MREC and US for the diagnosis of ulcer healing in the terminal ileum and colon
|
8-10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy fCal
Time Frame: 8-10 weeks
|
Sensitivity and specificity of fecal calprotectin for the diagnosis of ulcer healing in the terminal ileum and colon
|
8-10 weeks
|
Diagnostic accuracy CRP
Time Frame: 8-10 weeks
|
Sensitivity and specificity of C-reactive protein for the diagnosis of ulcer healing in the terminal ileum and colon
|
8-10 weeks
|
Bowel wall thickening
Time Frame: 8-10 weeks
|
Changes of bowel wall thickening (mm) assessed with US under medical treatment of Crohn's disease
|
8-10 weeks
|
Elastography
Time Frame: 8-10 weeks
|
Changes of shear wave elastography (m/s) assessed with US under medical treatment of Crohn's disease
|
8-10 weeks
|
Ultrasound activity index
Time Frame: 8-10 weeks
|
Changes of Limberg score assessed with US under medical treatment of Crohn's disease
|
8-10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael D Jensen, MD, PhD, Lillebaelt Hospital Vejle
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANDI-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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