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

NCT01736046 | Completed

• 1 other identifier: H12-02211
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

CT Enterography; Crohn's Disease; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity of Low Dose and Standard dose CTE for detecting active Crohn's Disease

  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.

  1 year

Secondary Outcomes (1)

• Correlation of Fecal Calprotectin with Radiology findings of Crohn's Disease

  1 year

Study Arms (1)

Crohn's Disease patients

All patients referred for CT Enterography will be undergo both standard and low dose CT Enterography

Radiation: CT Enterography

Interventions

CT Enterography RADIATION

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.

Also known as: CT Scan to include imaging of the small bowel and colon

Crohn's Disease patients

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suspected of having Crohn's Disease who are referred for CT Enterography examination by their gastroenterologist

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancovuer, British Columbia, V6M 3J9, Canada

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Brian Bressler, MD

  UBC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 29, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

CA (1)