Comparison of Standard and Low Dose CT Enterography for Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT01736046|
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : July 31, 2015
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|
|Study Type :||Observational|
|Actual Enrollment :||163 participants|
|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|
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
- 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.
- 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
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): NCT01736046
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancovuer, British Columbia, Canada, V6M 3J9|
|Principal Investigator:||Brian Bressler, MD||UBC|