IschemiaNCT03030872
Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion
An observational study of Ischemia, run by Carestream Health, Inc..
Trial summary
The objective of this study is to compare the diagnostic value of MR DSC-Perfusion (Perfusion Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with Perfusion and DWI Modules ("predicate device"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia
- What is being tested?
- Investigational software
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2017to 12 Jan 2017
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The study population will consist of retrospective de-identified adult patient MR DSC-Perfusion, DWI, and DTI (if available) cases collected under Ethics Committee/IRB approval. The Ethics Committee/IRB submission will request a waiver of patient informed consent in compliance with local country regulations, and must meet the study inclusion and exclusion criteria.
Who may be able to join
- Retrospective patient MR DSC-Perfusion cases with subject/patient 18 years of age or older.
- Retrospective patient MR DWI with subject/patient 18 years of age or older.
- Retrospective patient MR DTI cases with subject/patient 18 years of age or older.
- Informed consent is not required if waiver of consent is approved by the hospital IRB/Ethics Committee
Who cannot join
- Low quality images, or images that are not clinically acceptable for clinical diagnostic reading as determined by the Principal Investigator
- Subject less than 18 years of age
About this study
The objective of this study is to compare the diagnostic value of MR DSC-Perfusion (Perfusion Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with Perfusion and DWI Modules ("predicate device"). Therefore, there will be several separate objectives depending on the type of acquisition:
Read the detailed description
Carestream Health, Inc. will investigate the imaging performance of the CARESTREAM Vue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging ("investigational device") performance. Evaluation of MR Dynamic Susceptibility Contrast-Enhanced Perfusion Weighted Imaging (DSC-Perfusion), MR Diffusion Weighted Imaging (DWI) and MR Diffusion Tensor Imaging (DTI) was compared to the predicate device, the Olea Sphere PACS with Perfusion and DWI Modules. MR DSC-Perfusion of the brain is a method for evaluating blood flow in the brain and producing optimized parametric maps that help visualize this blood flow. MR DWI is a method to evaluate the motion of water molecules within bodily tissues. MR DTI is an extension of DWI that allows extraction of the diffusion tensor. The purpose of this study is to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to MR DSC-Perfusion, MR DWI, and MR DTI images.
- Conditions
- Ischemia
- Being tested
- Investigational software
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational softwareDevice
The study evaluated retrospective de-identified cases that were processed after the imaging procedure had been completed (off-line) using a dedicated workstation.
| Study group | Role | What they receive |
|---|---|---|
| Predicate software | Olea Sphere PACS with Perfusion and DWI Modules | |
| Investigational software | Vue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging Receives: Device: Investigational software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value comparison of Carestream Vue PACS v12.2 MR Perfusion and Diffusion (investigational software) images to the Olea Shere PACS with Perfusion and DWI Modules (predicate software) images.
Diagnostic value of investigational images compared to the diagnostic value of predicate images as assessed by a radiologist evaluation of key metrics.
Measured: January 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start7 Jan 2017
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carestream Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Pate, MS, RN, Study director, Senior Manager Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030872
- Sponsor's protocol ID
- AD0542
- Status last verified
- Mar 2018
- First submitted
- 23 Jan 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion
- ClinicalTrials.gov ID
- NCT03030872
- Acronym / sponsor ID
- AD0542
- Conditions
- Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Carestream Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2017 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 25 Jan 2017 (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 objective of this study is to compare the diagnostic value of MR DSC-Perfusion (Perfusion Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with Perfusion and DWI Modules ("predicate device"). Therefore, there will be several separate objectives depending on the type of acquisition:
Detailed description
Carestream Health, Inc. will investigate the imaging performance of the CARESTREAM Vue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging ("investigational device") performance. Evaluation of MR Dynamic Susceptibility Contrast-Enhanced Perfusion Weighted Imaging (DSC-Perfusion), MR Diffusion Weighted Imaging (DWI) and MR Diffusion Tensor Imaging (DTI) was compared to the predicate device, the Olea Sphere PACS with Perfusion and DWI Modules. MR DSC-Perfusion of the brain is a method for evaluating blood flow in the brain and producing optimized parametric maps that help visualize this blood flow. MR DWI is a method to evaluate the motion of water molecules within bodily tissues. MR DTI is an extension of DWI that allows extraction of the diffusion tensor. The purpose of this study is to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to MR DSC-Perfusion, MR DWI, and MR DTI images.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predicate software | – | –Olea Sphere PACS with Perfusion and DWI Modules |
| Investigational software | – | Device: Investigational softwareVue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of retrospective de-identified adult patient MR DSC-Perfusion, DWI, and DTI (if available) cases collected under Ethics Committee/IRB approval. The Ethics Committee/IRB submission will request a waiver of patient informed consent in compliance with local country regulations, and must meet the study inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Retrospective patient MR DSC-Perfusion cases with subject/patient 18 years of age or older.
- Retrospective patient MR DWI with subject/patient 18 years of age or older.
- Retrospective patient MR DTI cases with subject/patient 18 years of age or older.
- Informed consent is not required if waiver of consent is approved by the hospital IRB/Ethics Committee
Key exclusion criteria (2 listed)
- Low quality images, or images that are not clinically acceptable for clinical diagnostic reading as determined by the Principal Investigator
- Subject less than 18 years of age
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 |
|---|---|---|
| Investigational softwareThe study evaluated retrospective de-identified cases that were processed after the imaging procedure had been completed (off-line) using a dedicated workstation. | Device | Investigational software |
Primary outcome
Diagnostic value comparison of Carestream Vue PACS v12.2 MR Perfusion and Diffusion (investigational software) images to the Olea Shere PACS with Perfusion and DWI Modules (predicate software) images.
Time frame: January 2017
Diagnostic value of investigational images compared to the diagnostic value of predicate images as assessed by a radiologist evaluation of key metrics.
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 14 Nov 2018.
- 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.
Susan Pate, MS, RN study director
Senior Manager Clinical Affairs
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia, run by Carestream Health, Inc..
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 4 inclusion and 2 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Diagnostic value comparison of Carestream Vue PACS v12.2 MR Perfusion and Diffusion (investigational software) images to the Olea Shere PACS with Perfusion and DWI Modules (predicate software) images. (time frame: January 2017). 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 14 Nov 2018.