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Avicenna

CINA (for ICH and LVO)

  • Ischemic stroke
  • Intracranial Hemorrhage
  • CT
  • Non-contrast
  • Worklist Prioritisation
  • Large Vessel Occlusion

 

CINA is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images and CT angiographies of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of head CT images for Intracranial Hemorrhage (ICH) and CT angiographies of the head for large vessel occlusion (LVO).

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Images shown for illustrative purposes only.

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CINA (for ICH) uses deep learning to identify suspected intracranial hemorrhage (ICH) and prioritizes those cases in the worklist, reducing turnaround time for head trauma and stroke patients (vs standard assessment).1,2,3

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CINA (for ICH) performed well, with an accuracy of 95.6%, sensitivity of 91.4%, and specificity of 97.5%. ICH was further stratified into the following subtypes:

 

intraparenchymal, intraventricular, epidural/ subdural, and subarachnoid with true positive rates of 92.9, 100, 94.3, and 89.9%, respectively.3

 

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CINA (for LVO) performed well in the LVO cohort, with an accuracy of 98.1%, sensitivity of 98.1%, and specificity of 98.2%.3

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The algorithm also showed robust performance in detecting LVO location in a smaller subset of cases with an accuracy of 97.0%, sensitivity of 94.3%, and specificity of 97.4%.3

App gallery wave image

Clinical Workflow

CINA (for ICH)

ICH workflow

CINA (for LVO)

LVO workflow

For CalanticTM software version 1.0.0, no prior study will be examined.

*ICH refers to intracranial haemorrhage; SAH to subarachnoid haemorrhage; SDH to subdural haemorrhage; IPH to intraparenchymal haemorrhage; IVH to intraventricular haemorrhage; and EDH to epidural haemorrhage.

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    Appropriate Series for ICH

    Matrix size: ≥512x 512 (rectangular matrix accepted)

    Axial acquisition only

    Slice thickness: ≤5 mm

    Radiation dose parameters: 100 Kilovoltage peak (kVp) to 160 kVp, Mandatory Radiation dose parameters: 120 To 140 kVp, 150 to 400mAs

    Reconstruction diameter: above 170mm

    Soft tissue reconstruction kernel

     

    Appropriate Series for LVO

    Matrix size: ≥512x 512 (rectangular matrix accepted)

    Axial acquisition only

    Head First Supine (HFS) or Feet First Supine (FFS) patient position

    Slice thickness: ≤1.25mm

    Radiation dose parameters: 80 kVp to 140 kVp, Mandatory Radiation dose parameters: 100 to 120 kVp, 100 to 400 mAs

    Reconstruction diameter above 170mm, Arterial phase timing of contrast bolus as confirmed by mini test bolus or automatic bolus tracking software

    Arterial (or other sharp) reconstruction kernel

    CINA image processing applications provide a case-level notification in case of suspected positive findings to flag series in the Platform’s Worklist. This can be used to assist trained radiologists in workflow triage by flagging and communicating suspected positive findings of Intracranial Hemorrhage (ICH) and large vessel occlusion (LVO).

    In case of positive findings of ICH, the image processing application provides the user with the preview of the slices with a localization (delineation/contouring) where suspected positive findings of Intracranial Hemorrhage have been detected.

    In case of positive findings of LVO, the image processing application provides the user with the preview images (coronal and axial MIP) of the series with a localization (bounding box) where suspected positive findings of Large Vessel Occlusion have been detected.

      EU risk class and CE marking
      CINA has CE marking and risk class I.

      Reimbursement status
      Not reimbursed.

      Contraindications
      No contraindications given.

      Target population
      CINA (for ICH): Patients with suspected ICH.
      CINA (for LVO): Patients with suspected LVO.

      Intended user
      Trained radiologist.

      Limitations
      CINA may fail to flag and communicate suspected positive findings of non enhanced head CT images for Intracranial Hemorrhage (ICH) in the situations below:

      • not acute ICH,
      • small hemorrhage volume (< 3mL),
      • post contrast series,
      • inadequate field of view,
      • notable image noise,
      • motion artifacts,
      • severe metal artifacts.

       

      CINA may fail to detect Intraventricular hemorrhages (IVH) located in the inferior horn of the lateral ventricles on non enhanced head CT images CINA may fail to flag and communicate suspected positive findings of CT angiographies of the head for large vessel occlusion (LVO) in the situations below:

       
      • occlusion located outside the MCA M1, proximal MCA M2 or distal ICA,
      • small MCA occlusions (clot length <1.5 mm), particularly in presence of important collaterals,
      • series displaying no visible contrast due to bad bolus timing during the series acquisition process,
      • series containing improperly ordered slices (e.g. as a result of manual correction by an Imaging technician),
      • inadequate field of view,
      • motions artifacts,
      • severe metal artifacts.
        1.
        Instructions for Use CINA, software version 1.0
        2.
        CINA User Guide V01 release 10/2022 (AV-DP-CINA-10-013-SUM-USER-BF-V04-EN-OUS)
        3.
        Mclouth, J., & Elstrott, S., (2021): Validation of a Deep Learning Tool in the Detection of Intracranial Hemorrhage and Large Vessel Occlusion, 2021
        App gallery wave image
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