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MRI in Patients With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT02255019
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

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.


Condition or disease
Inflammatory Bowel Disease

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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: MRI in Patients With Inflammatory Bowel Disease
Study Start Date : May 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Group/Cohort
IBD, CD, UC
All patients should either have a known IBD diagnose or suspect of having IBD.



Primary Outcome Measures :
  1. Inflammation changes in gastrointestinal tract in MRI. [ Time Frame: 1 day ]
    Observe the inflammatory changes in bowel.

  2. evaluate MRI using faecal calprotectin (fC) as a reference standard. [ Time Frame: 1-3 days ]
    MRI is evaluated and fC is received about 3 day after MRI.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255019


Locations
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Denmark
Department of Diagnostic Radiology
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
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Principal Investigator: Kayalvily J. Nielsen, MD Copenhagen University Hospital at Herlev
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Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT02255019    
Other Study ID Numbers: H-2-2010-149
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis