Ulcerative Colitis Clinical Trial
The purpose of this study is to validate the use of a low-dose computed tomography (CT) protocol and facilitate reduced radiation doses in patients with inflammatory bowel disease (IBD). This is to be achieved using new computer software (Iterative Reconstruction and Automatic Tube Modulation) which will enable low-dose CT imaging at doses equivalent to that of an abdominal radiograph.
Status | Unknown status |
Enrollment | 250 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients requiring a CT abdomen for clinical purposes will be included Exclusion Criteria: - Pediatric patients |
Country | Name | City | State |
---|---|---|---|
Ireland | Cork University Hospital | Cork | Co Cork |
Lead Sponsor | Collaborator |
---|---|
University College Cork |
Ireland,
Desmond AN, O'Regan K, Curran C, McWilliams S, Fitzgerald T, Maher MM, Shanahan F. Crohn's disease: factors associated with exposure to high levels of diagnostic radiation. Gut. 2008 Nov;57(11):1524-9. doi: 10.1136/gut.2008.151415. Epub 2008 Apr 28. — View Citation
Kalra MK, Maher MM, Rizzo S, Kanarek D, Shepard JA. Radiation exposure from chest CT: issues and strategies. J Korean Med Sci. 2004 Apr;19(2):159-66. Review. Erratum in: J Korean Med Sci. 2004 Jun;19(3):487. Shephard JA [corrected to Shepard JA]. — View Citation
Kalra MK, Rizzo S, Maher MM, Halpern EF, Toth TL, Shepard JA, Aquino SL. Chest CT performed with z-axis modulation: scanning protocol and radiation dose. Radiology. 2005 Oct;237(1):303-8. — View Citation
Kalra MK, Wittram C, Maher MM, Sharma A, Avinash GB, Karau K, Toth TL, Halpern E, Saini S, Shepard JA. Can noise reduction filters improve low-radiation-dose chest CT images? Pilot study. Radiology. 2003 Jul;228(1):257-64. Epub 2003 May 15. — View Citation
O'Connor OJ, Vandeleur M, McGarrigle AM, Moore N, McWilliams SR, McSweeney SE, O'Neill M, Ni Chroinin M, Maher MM. Development of low-dose protocols for thin-section CT assessment of cystic fibrosis in pediatric patients. Radiology. 2010 Dec;257(3):820-9. doi: 10.1148/radiol.10100278. Epub 2010 Sep 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The adequacy of low dose CT in patients with Inflammatory bowel disease compared with standard dose CT | Radiation dose of a standard CT abdomen and pelvis will be divided into 2 quotients. A low-dose CT scan acquired using automatic tube current modulation (ATM) requiring 10% the dose of a standard abdominal CT and equating to that of a conventional abdominal radiograph. High noise index will be used ensuring reduced mAs. Increased image noise will be overcome by the IR filter. A second CT using 90% of the standard abdominal CT dose will ensure a diagnostic study is acquired. | At the time of CT | |
Secondary | The correlation of C-reactive protein assay with CT disease severity in inflammatory bowel disease. | The severity of inflammatory bowel disease will also be quantified based on the CT appearances. The disease severity as measured by CT will be correlated with C-reactive protein measured on the day of imaging. | CRP sample on same day as CT |
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