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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01736046
First received: November 6, 2012
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Crohn's Disease
Radiation: CT Enterography

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Sensitivity of Low Dose and Standard dose CTE for detecting active Crohn's Disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Correlation of Fecal Calprotectin with Radiology findings of Crohn's Disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Fecal Calprotectin levels will be measured and the results will be correlated with findings suggestive of Crohn's Disease on CT Enterography


Estimated Enrollment: 166
Study Start Date: December 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736046

Contacts
Contact: Greg Rosenfeld, MD 604-688-6332 grosenfeld@telus.net
Contact: Cherry Galorport 604-688-6332 cgalorport@gmail.com

Locations
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancovuer, British Columbia, Canada, V6M 3J9
Contact: Greg Rosenfeld, MD    604 688 56332    grosenfeld@telus.net   
Principal Investigator: Brian Bressler, MSc,MD         
Sub-Investigator: Greg Rosenfeld, MD         
Sub-Investigator: Jacquie Brown, MD         
Sub-Investigator: Patrick Vos, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Brian Bressler, MD UBC
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01736046     History of Changes
Other Study ID Numbers: H12-02211
Study First Received: November 6, 2012
Last Updated: March 26, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
CT Enterography
Crohn's Disease
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 24, 2014