在介入套房中使用双层探测器锥形束 CT 进行脑卒中评估：一项首例人体前瞻性队列研究（下一代 X 射线成像系统试验）。
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).
机构信息
Department of Neuroradiology, Karolinska University Hospital, Eugeniavägen 3, Stockholm, Sweden.
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
出版信息
Clin Neuroradiol. 2024 Dec;34(4):929-937. doi: 10.1007/s00062-024-01439-7. Epub 2024 Jul 25.
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.
目的
介入套房中的锥形束 CT 可能是缩短门到溶栓时间的 CT 替代方法。然而，锥形束 CT 的图像质量受到伪影和灰白质区分不良的限制。本研究比较了介入套房中非对比脑双层锥形束 CT 与中风患者的参考标准 CT。
方法
一项前瞻性单中心研究纳入了连续的缺血性或出血性中风患者。三位神经放射科医生对双层锥形束 CT 75keV 单能图像的脑出血检测准确性、各区域 ASPECTS 准确性和主观图像质量（用于灰白质区分、结构感知和伪影的李克特量表）进行评估，这些医生对双层锥形束 CT 75keV 单能图像的临床数据不知情。通过感兴趣区域指标评估客观图像质量。通过精确二项式检验确定出血检测和 ASPECTS 准确性的非劣效性，单侧下性能边界前瞻性设定为 80%（98.75%CI）。
结果
27 名参与者（74 岁±9；19 名女性）处于超急性期或急性期。一位读者错过了一个小出血，但在多数分析中所有出血均被检测到（100%的准确率，CI 下限 86%，p=0.002）。ASPECTS 多数分析显示 90%的准确率（CI 下限 85%，p<0.001）。敏感性为 66%（个别读者为 67%、69%和 76%），特异性为 97%（97%、96%和 89%）。主观和客观图像质量均劣于 CT。
结论
在一个小的单中心队列中，双层锥形束 CT 显示出与 CT 相比非劣的出血检测和 ASPECTS 准确性。尽管图像质量较差，但该技术可能对介入套房中的中风评估有用。
试验注册号
NCT04571099（clinicaltrials.gov）。2020 年 9 月 4 日前瞻性注册。
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