A Comparative Study of MRI, US and CE for Assessing Treatment Response in Known Crohn's Disease (NCT03435016) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.