RecruitingNCT06769594

Next Generation CT System

Clinical Feasibility and Evaluation of Silicon Photon Counting CT

Sponsor

GE Healthcare

Enrollment

100 participants

Start Date

Apr 8, 2025

Study Type

OBSERVATIONAL

Conditions

Computed Tomography

Summary

The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Subjects may be included in this study if they meet the following criteria:
Who are 18 year of age or older;
Able to sign and date the informed consent form; AND
Who have in the past 120 days or will in the future 30 days from the day of consent undergo a clinically indicated imaging exam (MRI, CT, radiograph, nuclear medicine, ultrasound, bone material density, interventional radiology procedure) of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior exam.

Exclusion Criteria8

Subjects may be excluded from participating in study if they meet any of the following 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 are in need of 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; and,
Who are unwilling to have GEHC personnel present for the CT exam.

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Interventions

DEVICEInvestigational CT Scan

All pre-contrast testing and administration of supporting medications shall be done according to the hospital's SOC. Images will then be compared with the previously acquired imaging conducted as standard of care. The investigational scan takes between 10-30 minutes.