ArteryNCT02747095
Clinical Investigation Plan for IQon Spectral CT at Utrecht Medical Center (UMC)
A study testing IQon Spectral CT in people with Artery and Deformity, run by Philips Healthcare at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artery, Deformity, Coronary (Acquired)
- What is being tested?
- IQon Spectral CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to 28 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Artery, Deformity, Coronary (Acquired)
- Being tested
- IQon Spectral CT
- Keywords
- CT, Spectral Images
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQon Spectral CTDevice
Using IQon Spectral CT, Assess the added diagnostic value and impact on workflow of spectral images
| Study group | Role | What they receive |
|---|---|---|
| Spectral CT image | Experimental | Interventions: IQon Spectral CT Receives: Device: IQon Spectral CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: One Year
Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.
Measured: 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
Measured: 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
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJan 2016
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- Tim Leiner, Principal investigator, Utrect Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747095
- Sponsor's protocol ID
- DHF246925
- Status last verified
- Jul 2017
- First submitted
- 15 Feb 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Plan for IQon Spectral CT at Utrecht Medical Center (UMC)
- ClinicalTrials.gov ID
- NCT02747095
- Acronym / sponsor ID
- DHF246925
- Conditions
- Artery, Deformity, Coronary (Acquired)
- Keywords
- CT, Spectral Images
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht
- Study start
- Jan 2016
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spectral CT image | Experimental | Device: IQon Spectral CTInterventions: IQon Spectral CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQon Spectral CTUsing IQon Spectral CT, Assess the added diagnostic value and impact on workflow of spectral images | Device | Spectral CT image |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Leiner principal investigator
Utrect Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQon Spectral CT in people with Artery and Deformity, run by Philips Healthcare at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.