Low-dose CT Using Iterative Reconstruction in Patients With Inflammatory Bowel Disease
NCT ID: NCT01244386
Last Updated: 2010-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
250 participants
OBSERVATIONAL
2010-06-30
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Inflammatory bowel disease
Patients with inflammatory bowel disease requiring CT for clinical purposes will be studied.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University College Cork
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University College Cork
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael M Maher, MD
Role: PRINCIPAL_INVESTIGATOR
University College Cork
Owen J O'Connor, MD
Role: STUDY_DIRECTOR
University College Cork
Fergus Shanahan, MD
Role: STUDY_DIRECTOR
University College Cork
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cork University Hospital
Cork, Co Cork, Ireland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Michael M Maher, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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. doi: 10.1148/radiol.2371041227.
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. doi: 10.1148/radiol.2281020606. Epub 2003 May 15.
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. doi: 10.3346/jkms.2004.19.2.159.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10-CT-Crohn's
Identifier Type: -
Identifier Source: org_study_id