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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 : November 22, 2022
Sponsor:
Collaborators:
Odense University Hospital
Hospital of South West Jutland
Information provided by (Responsible Party):
Michael Dam Jensen, Sygehus Lillebaelt

Study Description
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Brief Summary:

The aim of this study is to evaluate non-invasive imaging techniques for assessing treatment response in known Crohn's disease.

  1. 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.

    1. Sensitivity and specificity for ulcer healing
    2. Changes in activity parameters for SBCCE, MREC and US before and after medical treatment.
    3. Feasibility of SBCCE, MREC and US for assessing treatment response in known Crohn's disease.

  2. Treatment induced bowel wall alterations visualized with ultrasound:

    1. A non-blinded study of bowel wall changes detected with repeated US examination during medical treatment of known Crohn's disease.
    2. 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Diagnosis 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).
Other Names:
  • Ileocolonoscopy
  • MR enterocolonography
  • Ultrasound
  • Small bowel colon capsule endoscopy


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Bowel wall thickening [ Time Frame: 8-10 weeks ]
    Changes of bowel wall thickening (mm) assessed with US under medical treatment of Crohn's disease

  4. Elastography [ Time Frame: 8-10 weeks ]
    Changes of shear wave elastography (m/s) assessed with US under medical treatment of Crohn's disease

  5. Ultrasound activity index [ Time Frame: 8-10 weeks ]
    Changes of Limberg score assessed with US under medical treatment of Crohn's disease


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Michael D Jensen, MD, PhD 0045 7940 6345 michael.dam.jensen@rsyd.dk
Contact: Mie A Juel, MD 0045 7940 6345 mie.agerbaek.juel@rsyd.dk

Locations
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Denmark
Sygehus Lillebaelt Recruiting
Vejle, Denmark, 7100
Contact: Michael D Jensen, MD, PhD    0045 7940 6345    michael.dam.jensen@rsyd.dk   
Contact: Mie A Juel, MD    0045 7940 6345    mie.agerbaek.juel@rsyd.dk   
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         
Sponsors and Collaborators
Sygehus Lillebaelt
Odense University Hospital
Hospital of South West Jutland
Investigators
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Principal Investigator: Michael D Jensen, MD, PhD Lillebaelt Hospital Vejle
More Information
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Responsible Party: Michael Dam Jensen, Principal investigator, Sygehus Lillebaelt
ClinicalTrials.gov Identifier: NCT03435016    
Other Study ID Numbers: ANDI-2
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will not be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases