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CT Using MBIR in Crohn's Disease: Prospective Clinical Evaluation of Diagnostic Efficacy, Safety and Patient Outcome.

Primary Purpose

Radiology, Inflammatory Bowel Diseases

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Patients who have had split dose CT
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Radiology focused on measuring Computed tomography, Model based iterative reconstruction, Low dose CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with inflammatory bowel disease requiring CT to assess for disease complication

Exclusion Criteria:

  • Pregnancy or children

Sites / Locations

  • Cork University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low dose CT abdomen and pelvis

Control dose CT abdomen and pelvis

Arm Description

Low dose computed tomography

Control dose CT abdomen and pelvis

Outcomes

Primary Outcome Measures

Low-dose CT scanning of the abdomen and pelvis using Model Based Iterative Reconstruction (MBIR) in patients with inflammatory bowel disease: Clinical verification study
CT study assessing efficacy of reduced dose CT compared with normal dose CT

Secondary Outcome Measures

Full Information

First Posted
May 2, 2017
Last Updated
September 24, 2019
Sponsor
University College Cork
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1. Study Identification

Unique Protocol Identification Number
NCT03140306
Brief Title
CT Using MBIR in Crohn's Disease: Prospective Clinical Evaluation of Diagnostic Efficacy, Safety and Patient Outcome.
Official Title
Use of Low Dose CT Scanning of the Abdomen and Pelvis Using Model Based Iterative Reconstruction (MBIR) in Patients With Inflammatory Bowel Disease: Prospective Clinical Evaluation of Diagnostic Efficacy, Safety and Patient Outcome.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess the use of low dose CT reconstructed with MBIR for the assessment of patients with inflammatory bowel disease who need CT to assess for disease complications.
Detailed Description
The purpose of this study is to clinically validate the sole use of a low-dose computed tomography (CT) protocol to reduce the cumulative radiation dose in patients with inflammatory bowel disease. In an earlier study using the same CT parameters, the efficacy of the low dose technique was confirmed in the setting of a blinded retrospective review comparing the findings of the low dose and the conventional dose scan. The purpose of this study is to determine the reliability of the using low dose scan in a prospective clinical setting This is to be achieved using Model Based Iterative Reconstruction (MBIR) which has been shown to result in diagnostically acceptable low-dose CT imaging while providing a significant reduction of ionising radiation dose to the patient. The authors aim to apply MBIR to their low dose protocol, and to facilitate diagnostic quality CT scanning of the abdomen and pelvis at an effective dose approximately four times less than what would normally occur with an abdominopelvic CT in patients with suspected active Crohn's disease (CD). The authors plan to assess the diagnostic efficacy, safety and patient outcome of low dose CT reconstructed with MBIR in CD patients presenting to hospital with suspected acute mural and extramural complications. Patients with inflammatory bowel disease referred to Cork University Hospital (CUH) will undergo two series of the abdomen and pelvis: a modified low dose protocol designed to impart a radiation exposure of 10-20% that of a routine abdominal and pelvic CT and a conventional dose protocol designed to impart an effective dose of 80-90% that of a routine abdominal and pelvic CT. Using this strategy, the image quality and diagnostic yield of the low dose CT can be compared with that of the conventional dose CT and no patient will incur additional radiation exposure as a result of recruitment into the study. The low dose scan will be read alone initially by one of two experienced radiologists and the diagnostic report will come from this data set only. This report will be placed on the Picture Archiving and Communication System (PACS) to be used by the referring clinician who will then use the report/low dose scan images for patient management. This methodology is used to ascertain the clinical efficacy in a real world setting. One month after the initial low dose read, the two Radiologists will read the conventional dose CT scans. Note will be made on the PACS report of either agreement or discrepancy with the original low dose report. Any important discrepancy will be highlighted to the referring clinician by either phone and/or a radiological alert email.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiology, Inflammatory Bowel Diseases
Keywords
Computed tomography, Model based iterative reconstruction, Low dose CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Split dose CT
Masking
None (Open Label)
Masking Description
the reader of the ct is blinded to the clinical presentation
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose CT abdomen and pelvis
Arm Type
Experimental
Arm Description
Low dose computed tomography
Arm Title
Control dose CT abdomen and pelvis
Arm Type
Experimental
Arm Description
Control dose CT abdomen and pelvis
Intervention Type
Diagnostic Test
Intervention Name(s)
Patients who have had split dose CT
Intervention Description
Computed tomography
Primary Outcome Measure Information:
Title
Low-dose CT scanning of the abdomen and pelvis using Model Based Iterative Reconstruction (MBIR) in patients with inflammatory bowel disease: Clinical verification study
Description
CT study assessing efficacy of reduced dose CT compared with normal dose CT
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with inflammatory bowel disease requiring CT to assess for disease complication Exclusion Criteria: Pregnancy or children
Facility Information:
Facility Name
Cork University Hospital
City
Cork
State/Province
Co Cork
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34699288
Citation
O'Grady J, Carey BW, Kavanagh RG, O'Connell A, O'Connor OJ, Kenny-Walsh E, Zulquernain SA, Maher MM, Shanahan F. Making computed tomography safer for patients with Crohn's disease. Scand J Gastroenterol. 2022 Feb;57(2):175-182. doi: 10.1080/00365521.2021.1994640. Epub 2021 Oct 26.
Results Reference
derived

Learn more about this trial

CT Using MBIR in Crohn's Disease: Prospective Clinical Evaluation of Diagnostic Efficacy, Safety and Patient Outcome.

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