MRI in Patients With Inflammatory Bowel Disease

NCT02255019 | Completed

• 1 other identifier: H-2-2010-149
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to find an optimal magnetic resonance imaging (MRI) method to examine patients with inflammatory bowel disease (IBD). Patients should furthermore avoid being exposed to unnecessary X-rays and invasive examination. It is the investigators expectation that this study will benefit to future patients, as they will be offered MRI as the first choice. Hereby, the patients avoid the risks and discomfort associated with x-ray examinations. The aim is that patients with IBD achieve better and earlier treatment and if this is achieved it both benefits patient and public health. An earlier treatment leads to fewer hospitalizations and thereby saving the community money. The investigators hope is that the investigators study will show that MRI is one of the best tool to examine patients with IBD and that this in future leads MRI to be the first choice in contrary to all examinations with x-ray exposer, unless there is any contraindication to MRI.

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

• Inflammation changes in gastrointestinal tract in MRI.

  Observe the inflammatory changes in bowel.

  1 day

• evaluate MRI using faecal calprotectin (fC) as a reference standard.

  MRI is evaluated and fC is received about 3 day after MRI.

  1-3 days

Study Arms (1)

IBD, CD, UC

All patients should either have a known IBD diagnose or suspect of having IBD.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Minimum 77 subjects in study I-V and minimum 15 subjects in the pilot study are included. All patients should eighter have a known IBD diagnose or suspect IBD. There will not be considered healthy subjects. Participants must be over 18 years old.

You may qualify if:

• patients with known or suspected IBD
• age \> 18 years

You may not qualify if:

• age \< 18 years
• low kidney function (eGFR \< 30)
• contraindication for MRI (pacemaker, metal in the body, claustrophobia)
• dementia
• severe illness
• pregnancy/lactation

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Department of Diagnostic Radiology

Herlev, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patients will receive a faeces sample kit the first day they meet to MRI. The sample should be taken two days after the MRI scan and sent through the mail. The sample should contain about 5-10 g of faeces and it will be analyzed by ELISA method for calprotectin. Calprotectin is a good marker for the degree of inflammation in the intestines.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Kayalvily J. Nielsen, MD

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 2, 2014
• Study Start: May 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 2, 2014

Record last verified: 2014-09

Locations

DK (1)