CompletedNot Applicable

A Comparative Study of MRI, US and CE for Assessing Treatment Response in Known Crohn's Disease

Denmark62 participantsStarted 2018-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Diagnostic accuracy

Timeframe: 8-10 weeks

Trial details

NCT IDNCT03435016

SponsorSygehus Lillebaelt

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-01