Low-dose CT Using Iterative Reconstruction in Patients With Inflammatory Bowel Disease
|ClinicalTrials.gov Identifier: NCT01244386|
Recruitment Status : Unknown
Verified November 2010 by University College Cork.
Recruitment status was: Recruiting
First Posted : November 19, 2010
Last Update Posted : November 19, 2010
|Condition or disease|
|Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis|
The increasing use of CT has prompted the development of new scanning protocols which reduce radiation doses to patients and minimise the likelihood of radiation related morbidity. The use of disease specific low-dose CT examinations is an emerging method of limiting radiation doses.
Research conducted in Cork University Hospital(CUH) by the current authors has identified a pressing need to reduce radiation doses in patients with IBD. A retrospective study of radiation doses in patients with Crohn's disease demonstrated that increasing numbers of CT exams are performed with average cumulative effective doses rising from 7.9 to 25mSv when the first 5-years of the 15 year study period were compared with the final 5-years. Eight-five percent of the dose during the final 5-year period was due to CT. Younger patients with more severe disease requiring surgery or steroids were more likely to undergo an increased number of exams. 15.5% of patients received cumulative effective doses of greater than 75mSv. This quantity of radiation exposure is associated with a 7.3% increase in mortality from cancer. In addition, patients with Crohn's disease are inherently predisposed to gastrointestinal and hepatobiliary carcinoma and small bowel lymphoma.
As an alternative to CT, IBD patients are frequently imaging with conventional abdominal radiography. The effective dose of a conventional abdominal radiograph (CAR) is approximately 10% that of a standard abdominal CT varying between 0.7 -0.1mSv. The current authors have also investigated the value of CAR. We retrospectively examined over 500 CAR's performed over a 16 year period in patients with IBD. Patients had an average of 3.5 CAR's performed but there were positive findings in less than 30% of exams. Many of these findings were non-specific requiring further investigation. For example separation of bowel loops on a plain radiograph has a wide differential diagnosis including abscess formation, presence of a phlegmonous mass, fibrofatty proliferation, bowel wall thickening and lymphadenopathy.
Patients with inflammatory bowel disease referred to CUH will undergo a modified abdominal CT protocol. The radiation dose of a standard CT abdomen and pelvis will be divided into 2 quotients. Patients will have a low-dose CT scan requiring approximately 10% of the dose of a standard abdominal CT. This equates to the radiation dose of a conventional abdominal radiograph. Patients will be imaged with a second CT exam using 90% of the standard abdominal CT dose ensuring a diagnostic study is acquired. Patients will be given oral and intravenous contrast agents as for a standard CT. Patients will have a C-reactive protein measured on the day of CT and will have their heights and weights also measured at the time of scanning. Patients will have a plain film of abdomen performed prior to CT.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
Inflammatory bowel disease
Patients with inflammatory bowel disease requiring CT for clinical purposes will be studied.
- The adequacy of low dose CT in patients with Inflammatory bowel disease compared with standard dose CT [ Time Frame: At the time of 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.
- The correlation of C-reactive protein assay with CT disease severity in inflammatory bowel disease. [ Time Frame: CRP sample on same day as CT ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244386
|Contact: Michael M Maher, MD||+353 86 firstname.lastname@example.org|
|Contact: Owen J O'Connor, MD||USA 617 676 email@example.com|
|Cork University Hospital||Recruiting|
|Cork, Co Cork, Ireland|
|Contact: Michael M Maher, MD + 353 86 1731929 firstname.lastname@example.org|
|Principal Investigator:||Michael M Maher, MD||University College Cork|
|Study Director:||Owen J O'Connor, MD||University College Cork|
|Study Director:||Fergus Shanahan, MD||University College Cork|