NCT01244386

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

1.5 years

First QC Date

November 18, 2010

Last Update Submit

November 18, 2010

Conditions

Inflammatory Bowel DiseaseCrohn's DiseaseUlcerative Colitis

Keywords

Computed tomographyIterative reconstructionAutomatic tube current modulationCrohn's diseaseInflammatory bowel diseaseRadiation dose optimizationC reactive protein

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The correlation of C-reactive protein assay with CT disease severity in inflammatory bowel disease.

    CRP sample on same day as CT

Study Arms (1)

Inflammatory bowel disease

Patients with inflammatory bowel disease requiring CT for clinical purposes will be studied.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients under the care of the hospital gastrointestinal services including in-patients and outpatients.

You may qualify if:

  • Adult patients requiring a CT abdomen for clinical purposes will be included

You may not qualify if:

  • Pediatric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Co Cork, Ireland

RECRUITING

Related Publications (5)

  • 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.

    PMID: 18443021BACKGROUND

  • 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.

    PMID: 16183938BACKGROUND

  • 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.

    PMID: 12750460BACKGROUND

  • 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.

    PMID: 15082885BACKGROUND

  • 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.

    PMID: 20876388BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Michael M Maher, MD

    University College Cork

    PRINCIPAL INVESTIGATOR

  • Owen J O'Connor, MD

    University College Cork

    STUDY DIRECTOR

  • Fergus Shanahan, MD

    University College Cork

    STUDY DIRECTOR

Central Study Contacts

Michael M Maher, MD

CONTACT

+353 86 1731929m.maher@ucc.ie

Owen J O'Connor, MD

CONTACT

USA 617 676 7627owen.oconnor7@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations

IE(1)