A Comparative Study of MRI, US and CE for Assessing Treatment Response in Known Crohn's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03435016|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : February 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Diagnostic Test: Diagnostic work-up||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||March 1, 2020|
Diagnostic Test: Diagnostic work-up
Patients are examined with all modalities. MR enterocolonography, ultrasound, and small bowel capsule endoscopy are compared against ileocolonoscopy (gold standard).
- 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
- 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
- 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
- Bowel wall thickening [ Time Frame: 8-10 weeks ]Changes of bowel wall thickening (mm) assessed with US under medical treatment of Crohn's disease
- Elastography [ Time Frame: 8-10 weeks ]Changes of shear wave elastography (m/s) assessed with US under medical treatment of Crohn's disease
- Ultrasound activity index [ Time Frame: 8-10 weeks ]Changes of Limberg score assessed with US under medical treatment of Crohn's disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435016
|Contact: Michael D Jensen, MD, PhD||0045 7940 firstname.lastname@example.org|
|Contact: Mie A Juel, MD||0045 7940 email@example.com|
|Vejle, Denmark, 7100|
|Contact: Michael D Jensen, MD, PhD 0045 7940 6345 firstname.lastname@example.org|
|Contact: Mie A Juel, MD 0045 7940 6345 email@example.com|
|Principal Investigator: Michael D Jensen, MD, PhD|
|Sub-Investigator: Mie A Juel, MD|
|Sub-Investigator: Jacob B Brodersen, MD|
|Sub-Investigator: Jens Kjeldsen, Professor, PhD|
|Principal Investigator:||Michael D Jensen, MD, PhD||Lillebaelt Hospital Vejle|