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OpenTrials
Completed

NCT Number: NCT06769594

Next Generation CT System

The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting.

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Key information

Conditions

Computed Tomography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States

About this study

Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise to evaluate the product. This data and analysis will help support regulatory submission.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects may be included in this study if they meet the following criteria:

  • Who are 18 year of age or older;
  • Able to sign and date the informed consent form; AND
  • Who have in the past 120 days or will in the future 30 days from the day of consent undergo a clinically indicated imaging exam (MRI, CT, radiograph, nuclear medicine, ultrasound, bone material density, interventional radiology procedure) of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior exam.

Exclusion criteria

Subjects may be excluded from participating in study if they meet any of the following 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 are in need of 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; and,
  • Who are unwilling to have GEHC personnel present for the CT exam.

Treatment and study plan

Investigational CT Scan

Device

All pre-contrast testing and administration of supporting medications shall be done according to the hospital's SOC. Images will then be compared with the previously acquired imaging conducted as standard of care. The investigational scan takes between 10-30 minutes.

Primary outcomes

  1. Data Collection

    Time frame: 12 months

    Number of investigational CT scans along with standard of care CT images

Secondary outcomes

  1. Safety Information

    Time frame: 12 months

    Type and numbers of AEs, SAEs, and Device Deficiencies

  2. Assessment of Image Quality

    Time frame: 12 months

    Images created from the raw investigational CT scan data will be scored for image quality

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • University of Wisconsin, Madison

Registry information

Official study title

Clinical Feasibility and Evaluation of Silicon Photon Counting CT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Apr 29, 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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