CINA-ASPECTS is a computer-aided diagnosis software device used to assist clinicians, including stroke physicians and radiologists, in the assessment and characterization of brain tissue abnormalities using CT image data. Is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease and provides information that may be useful in the characterization of early ischemic (acute) brain tissue injury during image interpretation.¹

Images shown for illustrative purposes only.

Clinical Workflow

Scanning Parameters

Non-enhanced (non-contract) head CT images

Matrix size ≥256 x 256 (rectangular matrix accepted)

Axial acquisition only

Slice thickness ≤ 2.5 mm with no gap between successive slices

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

Radiation dose parameters: 100 kVp to 160 kVp, recommended: 120 to 140 kVp,

Reconstruction diameter above 170 mm,

Soft tissue reconstruction kernel.

Reconstruction diameter above 170 mm

Soft tissue reconstruction kernel.

AI Output

Series are processed by running the CINA-ASPECTS Image Processing Application on non-contrast head CT images (NCCT) and provides:

Two illustrative ASPECTS slices with the six cortical regions (M1-M6), and the four basal ganglia regions (caudate, lentiform, insula, and internal capsule).

A summary table with the information below:
- The automatically generated ASPECT score displayed in:
  - Red if it is less or equal to 5,
  - Orange if it is equal to 6 or 7,
  - White if its value is between 8 and 10,
The list of ASPECTS regions, identified as infarct, in which early ischemic change (low attenuation and/or sulcal effacement) has been identified,
The mean Hounsfield value within each ASPECTS region.

Other Relevant Information

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

Reimbursement status
Not reimbursed.

Contraindications

CINA-ASPECTS is not intended for use with head CT scans acquired in the presence of contrast media.
CINA-ASPECTS is not intended for use on head CT scans containing evidence of hemorrhage (intracranial, subarachnoid, microbleeds, etc.).
CINA-ASPECTS is not intended for use on head CT scans displaying neurological pathologies other than acute ischemic stroke, such as tumors or abscesses, or post-surgical conditions, such as craniectomy.

Target population

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

Limitations

Despite the data quality check performed by CINA-ASPECTS on DICOM data (please refer to section: Acquisition protocol requirements for an optimal use), the limitations below refer to situations in which the device ASPECTS may provide incorrect scoring:
- Inadequate field of view,
- Notable image noise,
- Significant motion artifacts,
- Severe streak artifacts,
Presence of chronic (old) infarcts. CINA-ASPECTS is not intended to detect chronic (old) infarcts and may incorrectly classify them as early ischemic changes.
The automatically generated ASPECT score is provided for informational purposes; the definite ASPECT being established by clinicians which are ultimately responsible for reviewing full images per the ASPECTS standard of care radiologist assessment.

References

Instructions for Use CINA-ASPECTS, software version 1.4

Shibata, S., Sakurai, K., Tachikawa, K., Ko, R., Hino, S., Fukano, T., Isahaya, K., Haraguchi, T., Yamauchi, J., Tanabe, K., Nagasaka, M., Hagiwara, Y., Shimizu, T., Akiyama, H., Kobayashi, Y., Hasegawa, Y., & Yamano, Y. (2022). The Utility of Automated ASPECTS in Acute Ischemic Stroke for Intravenous Recombinant Tissue Plasminogen Activator (IV-rtPA) Therapy. Neurology international, 14(4), 981–990. https://doi.org/10.3390/neurolint14040077