NCT03425032

Brief Summary

Computed tomography represents the mainstay for diagnosing various diseases in the whole body. Over the past decade, enormous efforts were undertaken by both CT manufacturers and radiologist to reduce the radiation dose to patients. Today, the dose is significantly lower that it was before the era of multislice CT and iterative reconstruction methods. The X-ray beam originating from the tube in a CT system contains a spectrum of different energies, whereby the "harder" beams with higher energy penetrate the patient better, and the "softer" beams will be absorbed through the patient's tissues. Recent research has been shown that the radiation dose can be further reduced by improved primary beam filtering in CT. This study is intended to compare the radiation dose in clinically indicated, routine CT examination while maintaining a diagnostic image quality, on a new CT system with modified primary beam filtering.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

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

Study Start

First participant enrolled

September 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

January 31, 2018

Last Update Submit

November 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Radiation dose

    Mean radiation dose (DLP), comparison to existing data (Radimetrics database)

    Through study completion, an average of 1 year

Interventions

Regular CT imaging of the abdomen and pelvis

Also known as: Genesis TSX-350A CT scanner

Eligibility Criteria

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

Patients will be routed to the new CT system in sequential order and as per clinical schedule. There will be no specific inclusion criteria for the study.

You may qualify if:

  • Patients who are clinically scheduled for a CT of the body (any part, or a combination of different parts).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Zhang G, Marshall N, Jacobs R, Liu Q, Bosmans H. Bowtie filtration for dedicated cone beam CT of the head and neck: a simulation study. Br J Radiol. 2013 Aug;86(1028):20130002. doi: 10.1259/bjr.20130002. Epub 2013 May 31.

  • Mail N, Moseley DJ, Siewerdsen JH, Jaffray DA. The influence of bowtie filtration on cone-beam CT image quality. Med Phys. 2009 Jan;36(1):22-32. doi: 10.1118/1.3017470.

  • Tkaczyk JE, Du Y, Walter D, Wu X, Li J, Toth T. Simulation of CT dose and contrast-to-noise as function of bowtie shape. Proc SPIE 2004;5368:403-410

    RESULT

MeSH Terms

Interventions

Tomography Scanners, X-Ray Computed

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Patrik Rogalla

    UHN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 7, 2018

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

January 1, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Image quality data will be stored in our clinical data base identical to SOC. We will not create a new database for the purpose of the study. Radiation dose measurements will also be stored in our clinical database identical to SOC. The selection of the patients for the purpose of the study (radiation dose to the population) is being performed through the Radimetrics software that sorts the database based on the CT equipment used. We will get a full list of all patients who were scanned on the new system, with a graphical display of the radiation dose distribution in relation to the other clinical CT. This feature is routinely used for all other clinical CT scanner