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Completed

NCT Number: NCT02747095

Clinical Investigation Plan for IQon Spectral CT at Utrecht Medical Center (UMC)

The CT examination on IQon Spectral CT would be a standard of care CT performed as per the clinical indication. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced. And therefore, the primary study aim is to assess the impact of IQon Spectral CT scanner and applications on the clinical workflow of the site as well as the diagnostic confidence levels of the physicians reading the CT cases.

In addition to the aim mentioned above, the investigators would like to develop recommendations for the clinical application of the spectral images in routine use. Such recommendations could include optimization of scanning protocols, optimization of reconstruction parameters; evaluate the utility of iodine maps and other supported materials.

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Key information

Conditions

Artery Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary (Acquired) Deformity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Utrecht Medical Center

Utrecht, 3584 CX, Netherlands

About this study

The study aim is to assess the added diagnostic value and impact on workflow of Philips IQon Spectral Computed Tomography.

The IQon Spectral CT generates two result types:

  • Conventional CT images which are equivalent to images produced by the commercially available Brilliance iCT scanner
  • Spectral CT images which are unique to this product.

The CT examination would be a standard of care CT performed as per the clinical indication.

In addition to the aim mentioned above, the investigators would like to develop recommendations for the clinical application of the spectral images in routine use. Such recommendations could include optimization of scanning parameters, optimization of reconstruction parameters to utilize the capabilities of the IQon system etc.

The clinical system includes:

  • The IQon Spectral CT scanner
  • Spectral Diagnostic suite (Philips IntelliSpace Portal): includes 5 applications. Spectral Enhanced CT Viewer, Spectral Enhanced Advanced Analysis, Spectral Enhanced Comprehensive Cardiac Analysis, Spectral Enhanced Tumor Tracking, spectral magic glass on PACS.

The testing will be conducted under this project plan. This is a single center research study that is expected to be conducted over a one year period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects clinically indicated to have a CT scan as part of their routine, standard medical care. Subjects must be capable of providing informed consent for the retrospective use and analysis of the IQon Spectral CT data for the research study.

Exclusion criteria

  • Subjects that are not clinically indicated to have a CT scan as part of their routine, standard medical care. Subjects that are not capable of providing informed consent for the retrospective use and analysis of the IQon Spectral CT data for the research study.

Treatment and study plan

IQon Spectral CT

Device

Using IQon Spectral CT, Assess the added diagnostic value and impact on workflow of spectral images

Primary outcomes

  1. Degree of improvement in specificity (measures the proportion of negatives that are correctly identified) of spectral coronary CTA for detection of coronary stenoses in need of treatment over conventional coronary CTA

    Time frame: One Year

Secondary outcomes

  1. Change in sensitivity (measures the proportion of positives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.

    Time frame: One Year

  2. Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.

    Time frame: One Year

  3. Change in sensitivity (measures the proportion of positives that are correctly identified) of SDCT versus conventional CT scanning or characterizing carotid atherosclerotic plaque components

    Time frame: One Year

  4. Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning or characterizing carotid atherosclerotic plaque components

    Time frame: One Year

Sponsors and collaborators

Lead sponsor

Philips Healthcare

Industry

Collaborators

  • UMC Utrecht

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2016
Registry last updated
Aug 1, 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.

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