Clinical Feasibility and Evaluation of Silicon Photon Counting CT

NCT05838482 | Completed FDA Device

• 1 other identifier: 23000861577
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CT Photon-Counting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Image Quality

  1 year

Study Arms (1)

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

Interventions

CT Photon-Counting DEVICE

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.

Subject's Scanned with Investigational Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Study Officials

• Brian Thomsen

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: September 7, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

US (1)