Clinical Feasibility and Evaluation of Silicon Photon Counting CT

CT Photon-Counting Clinical Trial

Official title:

Clinical Feasibility and Evaluation of Silicon Photon Counting CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838482
• Other study ID #: 23000861577
• Status: Recruiting
• Start date: September 7, 2023
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: GE Healthcare
• Contact: Melissa Challman
• Phone: +1-858-221-3007
• Email: melissa.challman[@]gehealthcare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CT Photon-Counting

Intervention

Device:
• CT Photon-Counting
Enrolled subjects will complete an exam using the photon-counting CT, with or without IV contract as indicated. Images will then be compared with the previously acquired CT conducted as standard of care.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data Collection	Number of Participants with raw investigational photon-counting CT scan data along with prior standard of care diagnostic CT exam data/images	1 year
Secondary	Image Quality	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)	1 year