Clinical Feasibility and Evaluation of Silicon Photon Counting CT

Recruiting

• Conditions: CT Photon-Counting
• Interventions: Device: CT Photon-Counting

• Registration Number: NCT05838482
• Lead Sponsor: GE Healthcare

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 Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-01
• Study Start: 2023-09-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subject's Scanned with Investigational Device	CT Photon-Counting	Eligible and consented subjects will be scanned using the investigational Pluto Photon-Counting CT system.

Primary Outcome Measures

Name	Time	Method
Data Collection	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 Outcome Measures

Name	Time	Method
Image Quality	1 year	Reconstructed images produced from the raw investigational photon-counting CT scan will be scored for image quality using a Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality)

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States