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

July 30, 2017 updated by: Philips Healthcare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

980

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Utrecht Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spectral CT image
Interventions: IQon Spectral CT
Device: IQon Spectral CT
Using IQon Spectral CT, Assess the added diagnostic value and impact on workflow of spectral images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One Year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
One Year
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
One Year
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
One Year
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
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Healthcare

Collaborators

UMC Utrecht

Investigators

  • Principal Investigator: Tim Leiner, Utrect Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

April 28, 2017

Study Completion (Actual)

April 28, 2017

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 30, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHF246925

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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