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Comparison of Standard and Low Dose CT Enterography for Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01736046
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : July 31, 2015
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:

The investigators will be assessing the efficacy of a Model Based Iterative Reconstruction algorithm (MBIR) as a noise reduction tool in computed tomographic (CT) examinations for Crohn's Disease. MBIR is computer adapted mathematical calculation technique that generates CT images with less picture degradation (noise) than traditional computer reconstruction techniques such as FBP (Filtered Back Projection) and ASIR (Adaptive Statistical Iterative Reconstruction), for enteric Crohn's Disease findings.

The research involves collection of data from subjects standard of care diagnostic CT scan and from a research low radiation dose scan performed immediately following their diagnostic scan. We will determine the impact on image quality, interpretability, and Crohn's Disease findings of the low dose scan compared to the standard of care scan.

FBP, MBIR, and ASIR are post processing tools that do not alter the scan acquisition itself.

Condition or disease Intervention/treatment
Crohn's Disease Radiation: CT Enterography

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Study Type : Observational
Actual Enrollment : 163 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of CT Reconstruction Algorithm on the Quantitative Assessment of Crohn's Disease: A Comparison of Standard and Low Dose CT Enterography
Study Start Date : December 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
Crohn's Disease patients
All patients referred for CT Enterography will be undergo both standard and low dose CT Enterography
Radiation: CT Enterography

Diagnostic CT Enterography Scan (CTE)

Subjects will have their scheduled diagnostic CTE scan done according to St. Paul's Hospital radiology department standard procedures. Subjects will be randomly assigned to undergo a low dose CT Enterography scan either before or after the diagnostic scan. The radiologists who are blinded to the technique used will then interpret the scans to look for signs of Crohn's disease. The low dose scan will be compared to the standard scan in terms of it's ability to detect signs of Crohn's disease.

Other Name: CT Scan to include imaging of the small bowel and colon

Primary Outcome Measures :
  1. Sensitivity of Low Dose and Standard dose CTE for detecting active Crohn's Disease [ Time Frame: 1 year ]
    FBP, ASIR and MBIR will each be compared to the reference standard. The endpoint will be the ability of each method to accurately identify the presence or absence of Crohn's Disease (CD) as compared to the reference standard.

Secondary Outcome Measures :
  1. Correlation of Fecal Calprotectin with Radiology findings of Crohn's Disease [ Time Frame: 1 year ]
    Fecal Calprotectin levels will be measured and the results will be correlated with findings suggestive of Crohn's Disease on CT Enterography

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suspected of having Crohn's Disease who are referred for CT Enterography examination by their gastroenterologist

Inclusion Criteria:

  • Patients age 19 years or older with suspected or known inflammatory bowel disease referred to the St. Paul's Hospital Radiology department for CT Enterography examination will be eligible to participate.

Exclusion Criteria:

  • Patients unable to tolerate oral contrast media ( PegLyte (polyethylene glycol) for bowel distension or with kidney disease (gfr<60) where intravenous contrast would be contraindicated.
  • Patients with a known or suspected allergy/reaction to contrast material.
  • Pregnant patients Note: As per standard of care in the SPH radiology department, a screening pregnancy test will be done if the patient is of child bearing potential and is not sure that they are pregnant.
  • Patients who are unwilling to sign the consent form will not be eligible for participation.

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 identifier (NCT number): NCT01736046

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Canada, British Columbia
St. Paul's Hospital
Vancovuer, British Columbia, Canada, V6M 3J9
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Brian Bressler, MD UBC

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Responsible Party: University of British Columbia Identifier: NCT01736046    
Other Study ID Numbers: H12-02211
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Keywords provided by University of British Columbia:
CT Enterography
Crohn's Disease
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases