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

NCT02747095 | Completed

• 1 other identifier: DHF246925
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 1

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.

Conditions

Artery; Deformity; Coronary (Acquired)

Keywords

CT; Spectral Images

Outcome Measures

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

  One Year

Secondary Outcomes (4)

• 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.

  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

  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

  One Year

Study Arms (1)

Spectral CT image

EXPERIMENTAL

Interventions: IQon Spectral CT

Device: IQon Spectral CT

Interventions

IQon Spectral CT DEVICE

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

Spectral CT image

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Healthcare: lead
• UMC Utrecht: collaborator

Study Sites (1)

Utrecht Medical Center

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tim Leiner

  Utrect Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: April 21, 2016
• Study Start: January 1, 2016
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)