Stroke Evaluation in the Interventional Suite Using Dual-Layer Detector Cone-Beam CT: a First-in-human Prospective Cohort Study (the Next Generation X-ray Imaging System Trial).

Purpose: Cone-beam CT in the interventional suite could be an alternative to CT to shorten door-to-thrombectomy time. However, image quality in cone-beam CT is limited by artifacts and poor differentiation between gray and white matter. This study compared non-contrast brain dual-layer cone-beam CT in the interventional suite to reference standard CT in stroke patients.

Methods: A prospective single-center study enrolled consecutive participants with ischemic or hemorrhagic stroke. The hemorrhage detection accuracy, per-region ASPECTS accuracy and subjective image quality (Likert scales for gray-white matter differentiation, structure perception and artifacts) were assessed by three neuroradiologists blinded to clinical data on dual-layer cone-beam CT 75 keV monoenergetic images compared to CT. Objective image quality was assessed by region-of-interest metrics. Non-inferiority for hemorrhage detection and ASPECTS accuracy was determined by the exact binomial test with a one-sided lower performance boundary prospectively set to 80% (98.75% CI).

Results: 27 participants were included (74 years ± 9; 19 female) in the hyperacute or acute stroke phase. One reader missed a small bleeding, but all hemorrhages were detected in the majority analysis (100% accuracy, CI lower boundary 86%, p = 0.002). ASPECTS majority analysis showed 90% accuracy (CI lower boundary 85%, p < 0.001). Sensitivity was 66% (individual readers 67%, 69%, and 76%), specificity was 97% (97%, 96%, 89%). Subjective and objective image quality were inferior to CT.

Conclusion: In a small single-center cohort, dual-layer cone-beam CT showed non-inferior hemorrhage detection and ASPECTS accuracy to CT. Despite inferior image quality, the technique may be useful for stroke evaluation in the interventional suite.

Trial registration number: NCT04571099 (clinicaltrials.gov). Prospectively registered 2020-09-04.