Clinical Feasibility and Evaluation of Silicon Photon Counting CT

NCT ID: NCT05838482

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-07

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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CT Photon-Counting

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subject's Scanned with Investigational Device

Eligible and consented subjects will be scanned using the investigational Pluto Photon-Counting CT system.

CT Photon-Counting

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Thomsen

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa Challman

Role: CONTACT

Phone: +1-858-221-3007

Email: [email protected]

Facility Contacts

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Adam Wang

Role: primary

Other Identifiers

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23000861577

Identifier Type: -

Identifier Source: org_study_id