Clinical Feasibility and Evaluation of Silicon Photon Counting CT

General Electric (GE)

Status

Enrolling

Conditions

CT Photon-Counting

Treatments

Device: CT Photon-Counting

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05838482

23000861577

Details and patient eligibility

About

The purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.