Clinical Feasibility and Evaluation of Silicon Photon Counting CT
NCT ID: NCT05838482
Last Updated: 2025-11-06
Study Results
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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RECRUITING
100 participants
OBSERVATIONAL
2023-09-07
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
GE Healthcare
INDUSTRY
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Adam Wang
Role: primary
Other Identifiers
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23000861577
Identifier Type: -
Identifier Source: org_study_id