Clinical Feasibility and Evaluation of Silicon Photon Counting CT

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

Study Overview

• Status: Recruiting
• Conditions: CT Photon-Counting
• Intervention / Treatment: Device: CT Photon-Counting

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 Type: Observational
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Challman; Phone Number: +1-858-221-3007; Email: melissa.challman@gehealthcare.com

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Adam Wang; Phone Number: 650-498-1765; Email: adamwang@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The subject population will consist of adults that are 18-years of age or older, and who have undergone a prior clinically-indicated CT exam of at least one of the following anatomical area(s): head, neck, heart, chest, abdomen, pelvis, and/or extremities.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Stanford University
• Investigators: Study Director: Brian Thomsen, GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 23000861577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Scan data will be shared with other researchers but all will be completely deidentified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No