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

NCT03435016 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-11-28

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

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).

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Sygehus Lillebaelt

    lead OTHER

Principal Investigators

  • Michael D Jensen, MD, PhD · Lillebaelt Hospital Vejle

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2023-03-01
Completion
2023-06-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03435016 on ClinicalTrials.gov