NCT05838482CompletedNot Applicable
Clinical Feasibility and Evaluation of Silicon Photon Counting CT
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GE Healthcare
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Data Collection
Study Overview
Brief Summary
The purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting.
Detailed Description
Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise that will evaluate the product and how this photon-counting CT technology can be used to reduce the overall radiation dose in CT imaging, and enhance clinical applications for CT technology. This data and analysis will help support regulatory submission.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Who are 18 years of age or older
- •Able to sign and date the informed consent form
- •Who have in the past 120 days or will in the future 30 days undergo a clinically-indicated CT exam of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior scheduled exam
Exclusion Criteria
- •Who are pregnant or lactating;
- •Who were previously enrolled in this study;
- •For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents
- •For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
- •Who need urgent or emergent care;
- •Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR
- •Who are unwilling to have GEHC personnel present for the CT exam.
Outcomes
Primary Outcomes
Data Collection
Time Frame: 1 year
Number of Participants with raw investigational photon-counting CT scan data along with prior standard of care diagnostic CT exam data/images
Secondary Outcomes
- Image Quality(1 year)
Investigators
Study Sites (2)
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