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

Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747095
• Other study ID #: DHF246925
• Status: Completed
• Phase: N/A
• First received: February 15, 2016
• Last updated: July 30, 2017
• Start date: January 2016
• Est. completion date: April 28, 2017

Study information

• Verified date: July 2017
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Artery
• Coronary (Acquired)
• Deformity

Intervention

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

Locations

Country	Name	City	State
Netherlands	Utrecht Medical Center	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Philips Healthcare	UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		One Year
Secondary	Change in sensitivity (measures the proportion of positives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.		One Year
Secondary	Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.		One Year
Secondary	Change in sensitivity (measures the proportion of positives that are correctly identified) of SDCT versus conventional CT scanning or characterizing carotid atherosclerotic plaque components		One Year
Secondary	Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning or characterizing carotid atherosclerotic plaque components		One Year