NCT03140306

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

May 2, 2017

Last Update Submit

September 24, 2019

Conditions

RadiologyInflammatory Bowel Diseases

Keywords

Computed tomographyModel based iterative reconstructionLow dose CT

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Study Arms (2)

Low dose CT abdomen and pelvis

EXPERIMENTAL

Low dose computed tomography

Diagnostic Test: Patients who have had split dose CT

Control dose CT abdomen and pelvis

EXPERIMENTAL

Control dose CT abdomen and pelvis

Diagnostic Test: Patients who have had split dose CT

Interventions

Patients who have had split dose CTDIAGNOSTIC_TEST

Computed tomography

Control dose CT abdomen and pelvisLow dose CT abdomen and pelvis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy or children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Co Cork, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 34699288DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
the reader of the ct is blinded to the clinical presentation
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Split dose CT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

October 24, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)