Clinical Investigation Plan for IQon Spectral CT at Utrec... | NCT02747095

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

NCT02747095

Sponsor

Philips Healthcare

Status

Completed

Last Update Posted

Aug 1, 2017Actual

Enrollment

980Actual

Phase

Not Applicable

Conditions

Artery
Deformity
Coronary (Acquired)

Interventions

IQon Spectral CT

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Apr 28, 2017Actual

Completion Date

Apr 28, 2017Actual

First Submitted Date

Feb 15, 2016

First Submission Date that Met QC Criteria

Apr 18, 2016

First Posted Date

Apr 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2017

Last Update Posted Date

Aug 1, 2017Actual

Name	Class
UMC Utrecht	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

980Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spectral CT image	Experimental	Interventions: IQon Spectral CT	Device: IQon Spectral CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IQon Spectral CT	Device	Using IQon Spectral CT, Assess the added diagnostic value and impact on workflow of spectral images	Spectral CT image

Outcomes Module

Primary Outcomes

Measure	Description	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		One Year

Secondary Outcomes

Measure	Description	Time Frame
Change in sensitivity (measures the proportion of positives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.		One Year
Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tim Leiner	Utrect Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Utrecht Medical Center		Utrecht		3584 CX	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000013	Congenital Abnormalities

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided