- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03425032
Low-dose Whole Body Computed Tomography Scanning
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who are clinically scheduled for a CT of the body (any part, or a combination of different parts).
Exclusion Criteria:
- There are no exclusion criteria for the purpose of this study. Patients must able to consent to the study participation.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation dose
Time Frame: Through study completion, an average of 1 year
|
Mean radiation dose (DLP), comparison to existing data (Radimetrics database)
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrik Rogalla, UHN
Publications and helpful links
General 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.
- 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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16-5477
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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