Status:
COMPLETED
A Comparative Study of MRI, US and CE for Assessing Treatment Response in Known Crohn's Disease
Lead Sponsor:
Sygehus Lillebaelt
Collaborating Sponsors:
Odense University Hospital
Esbjerg Hospital - University Hospital of Southern Denmark
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03435016
Start Date
February 1 2018
End Date
June 1 2023
Last Update
November 28 2023
Active Locations (1)
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1
Sygehus Lillebaelt
Vejle, Denmark, 7100