Trial reportClinical neuroradiology2024
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).
Trial report in Clinical neuroradiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04571099 (Next Generation X-ray Imaging System), which is not on this map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Next Generation X-ray Imaging System
Who cites it
3 citing papers in PubMed.
- Brain cone-beam CT image quality improvement using a deep-learning-based denoising method: a multicenter retrospective study.Neuroradiology · 2026Article
- Diagnostic Accuracy of Ischemia and Hemorrhage on Cone-Beam CT Immediately After Endovascular Thrombectomy.Stroke (Hoboken, N.J.) · 2026Article
- The Applications of Spectral CT in Interventional Radiology: Innovations in Diagnosis and Intra-procedural Guidance.Cardiovascular and interventional radiology · 2026Review
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
purposeCone-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.
methodsA 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).
results27 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.
conclusionIn 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.
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