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OpenTrials
Completed

NCT Number: NCT02731937

Clinical Evaluation of a Dual Energy CT System

The main purpose of this study is to collect clinical raw scan data and Scanner user feedback using dual energy CT (computed tomography) scan modes on the investigational CT scanner. Additionally, image quality using prototype reconstruction algorithms that are in development will be evaluated and compared to standard-of-care images acquired with regulatory cleared diagnostic CT scanners for feasibility assessment and engineering development. Compared to standard clinical single energy (kilovolt,kV) scanning, dual energy (kV) scanning s provides more information about the material composition of the scanned patient and may allow for improved tissue, tumor characterization, and improved image quality.

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Key information

Conditions

General CT Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Who are 18 year of age or older;
  • Able to sign and date the informed consent form; AND
  • Who have in the past year undergone a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities

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 are in need of urgent or emergent care;
  • Diabetic patients on metformin (Glucophage)
  • 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

GE Healthcare Revolution CT Scanner (CT Scanner)

Device

Raw CT Scan Data

Other names: CT scanner

Primary outcomes

  1. Raw CT Scan Data

    Time frame: 3 months

    No outcome assessment is currently planned. Up to 60 subjects will be scanned using GE Healthcare's Revolution CT scanner for future engineering and regulatory purposes.

Secondary outcomes

  1. Image Quality assessment

    Time frame: 3 months

    Likert Scale to assess image quality

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2016
Registry last updated
May 8, 2017

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.