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OpenTrials
Completed

NCT Number: NCT05838482

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Data Collection

    Time frame: 1 year

    Number of Participants with raw investigational photon-counting CT scan data along with prior standard of care diagnostic CT exam data/images

Secondary outcomes

  1. Image Quality

    Time frame: 1 year

    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)

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Stanford University

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 1, 2023
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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