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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT03435016
• Date of registration: 02/02/2018
• Prospective Registration: No
• Primary sponsor: Sygehus Lillebaelt
• Public title: A Comparative Study of MRI, US and CE for Assessing Treatment Response in Known Crohn's Disease
• Scientific 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
• Date of first enrolment: February 1, 2018
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03435016
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Michael D Jensen, MD, PhD
• Affiliation: Lillebaelt Hospital Vejle

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Diagnostic Test: Diagnostic work-up

Primary Outcome(s)

Diagnostic accuracy [Time Frame: 8-10 weeks]

Secondary Outcome(s)

Diagnostic accuracy CRP [Time Frame: 8-10 weeks]

Diagnostic accuracy fCal [Time Frame: 8-10 weeks]

Elastography [Time Frame: 8-10 weeks]

Ultrasound activity index [Time Frame: 8-10 weeks]

Bowel wall thickening [Time Frame: 8-10 weeks]

Secondary ID(s)

ANDI-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Odense University Hospital

Hospital of South West Jutland