Computed TomographyNCT03425032
Low-dose Whole Body Computed Tomography Scanning
An observational study of Computed Tomography and Image Quality, run by University Health Network, Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Computed Tomography, Image Quality
- What is being tested?
- CT scanner
- Type of treatment
- Medical device
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who are clinically scheduled for a CT of the body (any part, or a combination of different parts).
Who cannot join
- There are no exclusion criteria for the purpose of this study. Patients must able to consent to the study participation.
About this study
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.
Read the detailed description
At the Joint Department of Medical Imaging (JDMI), the investigators periodically adjust the radiation dose and modify the clinical imaging protocols in order to continuously optimize image quality in CT. The investigators have formalized the process of radiation dose adjustments by implementing a CT dose committee that meets on a monthly basis and reviews imaging protocols (SOP). The committee includes radiologists, technologists, vendor representative (if needed), managers and the radiation protection officer. Part of the review is the investigator's in-house developed Coral image quality review program as well as the clinically used radiation dose monitoring software (Radiometric).
Part of the evaluation study of the new CT system is to monitor 520 patients who will undergo a clinically indicated CT scan on the new system. Identical to standard-of-care (SOC) quality insurance, the investigators will use the existing monitoring software (Radiometric, JDMI) in order to capture the data in the existing database. The investigators will also capture quality data through the existing CT image quality feedback tool. After installation of the new CT system, the investigators will maintain the radiation dose as currently applied in the standard JDMI wide imaging protocols and examine 20 patients on the new system; radiation dose and image quality feedback will be recorded in the identical fashion to standard operating procedures (CT image quality and radiation dose committee). Subsequently, the investigators will drop the dose by approx. 10% for each scanning protocol and scan the subsequent 250 patients while concurrently analyzing the impact on the collective dose to the patient population. Based on the expected increase in image noise, the investigators will calculate the possible additional dose reduction in percent and modify all protocols accordingly for the subsequent 250 patients. This step-down approach ensures that no CT scan will be performed with too little dose, and that all CT scans remain diagnostic.
- Conditions
- Computed Tomography, Image Quality
- Being tested
- CT scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scannerDevice
Also called Genesis TSX-350A CT scanner
Regular CT imaging of the abdomen and pelvis
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose
Mean radiation dose (DLP), comparison to existing data (Radimetrics database)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study startSep 2016
- Primary completionMar 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Computed TomographyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrik Rogalla, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425032
- Sponsor's protocol ID
- 16-5477
- Status last verified
- Nov 2018
- First submitted
- 31 Jan 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 23728948Mail 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.
PubMed 19235370Tkaczyk 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Whole Body Computed Tomography Scanning
- ClinicalTrials.gov ID
- NCT03425032
- Acronym / sponsor ID
- 16-5477
- Conditions
- Computed Tomography, Image Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At the Joint Department of Medical Imaging (JDMI), the investigators periodically adjust the radiation dose and modify the clinical imaging protocols in order to continuously optimize image quality in CT. The investigators have formalized the process of radiation dose adjustments by implementing a CT dose committee that meets on a monthly basis and reviews imaging protocols (SOP). The committee includes radiologists, technologists, vendor representative (if needed), managers and the radiation protection officer. Part of the review is the investigator's in-house developed Coral image quality review program as well as the clinically used radiation dose monitoring software (Radiometric).
Part of the evaluation study of the new CT system is to monitor 520 patients who will undergo a clinically indicated CT scan on the new system. Identical to standard-of-care (SOC) quality insurance, the investigators will use the existing monitoring software (Radiometric, JDMI) in order to capture the data in the existing database. The investigators will also capture quality data through the existing CT image quality feedback tool. After installation of the new CT system, the investigators will maintain the radiation dose as currently applied in the standard JDMI wide imaging protocols and examine 20 patients on the new system; radiation dose and image quality feedback will be recorded in the identical fashion to standard operating procedures (CT image quality and radiation dose committee). Subsequently, the investigators will drop the dose by approx. 10% for each scanning protocol and scan the subsequent 250 patients while concurrently analyzing the impact on the collective dose to the patient population. Based on the expected increase in image noise, the investigators will calculate the possible additional dose reduction in percent and modify all protocols accordingly for the subsequent 250 patients. This step-down approach ensures that no CT scan will be performed with too little dose, and that all CT scans remain diagnostic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who are clinically scheduled for a CT of the body (any part, or a combination of different parts).
Key exclusion criteria (1 listed)
- There are no exclusion criteria for the purpose of this study. Patients must able to consent to the study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scannerAlso: Genesis TSX-350A CT scannerRegular CT imaging of the abdomen and pelvis | Device | – |
Primary outcome
Radiation dose
Time frame: Through study completion, an average of 1 year
Mean radiation dose (DLP), comparison to existing data (Radimetrics database)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Results publication: PubMed 23728948Zhang 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.
- Results publication: PubMed 19235370Mail 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.
- Results publicationTkaczyk 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
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrik Rogalla principal investigator
UHN
Questions about this trial
What is this clinical trial studying?
An observational study of Computed Tomography and Image Quality, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425032, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.