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).

IF 2.8 3区 医学 Q2 Medicine
Clinical Neuroradiology Pub Date : 2024-12-01 Epub Date: 2024-07-25 DOI:10.1007/s00062-024-01439-7
Fredrik Ståhl, Håkan Almqvist, Åsa Aspelin, Jens Kolloch, Odett Ghalamkari, Vamsi Gontu, Dirk Schäfer, Peter van de Haar, Klaus-Jürgen Engel, Fred van Nijnatten, Åke Holmberg, Michael V Mazya, Michael Söderman, Anna Falk Delgado
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引用次数: 0

Abstract

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.

Abstract Image

在介入室使用双层探测器锥形束 CT 进行中风评估:首次人体前瞻性队列研究(下一代 X 射线成像系统试验)。
目的:介入手术室中的锥形束 CT 可以替代 CT,缩短从门诊到血栓切除术的时间。然而,锥束 CT 的图像质量受到伪影和灰质与白质区分度差的限制。本研究将介入治疗室的非对比脑双层锥形束 CT 与中风患者的参考标准 CT 进行了比较:一项前瞻性单中心研究连续招募了缺血性或出血性脑卒中患者。由三位神经放射科医生对双层锥形束 CT 75 keV 单能量图像与 CT 的临床数据进行盲法评估,比较出血检测准确性、每个区域 ASPECTS 准确性和主观图像质量(灰白质区分、结构感知和伪影的李克特量表)。客观图像质量通过感兴趣区指标进行评估。出血检测和 ASPECTS 准确性的非劣效性通过精确二项检验确定,单侧性能下限前瞻性设定为 80% (98.75% CI)。一名读者漏检了少量出血,但在多数分析中发现了所有出血(准确率 100%,CI 下限 86%,P = 0.002)。ASPECTS 多数分析的准确率为 90%(CI 下限为 85%,P=0.002):在一个小型单中心队列中,双层锥束 CT 的出血检测和 ASPECTS 准确率均不低于 CT。尽管图像质量较差,但该技术仍可用于介入治疗室的卒中评估:NCT04571099(clinicaltrials.gov)。前瞻性注册 2020-09-04。
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来源期刊
Clinical Neuroradiology
Clinical Neuroradiology Medicine-Radiology, Nuclear Medicine and Imaging
CiteScore
4.90
自引率
3.60%
发文量
0
期刊介绍: Clinical Neuroradiology provides current information, original contributions, and reviews in the field of neuroradiology. An interdisciplinary approach is accomplished by diagnostic and therapeutic contributions related to associated subjects. The international coverage and relevance of the journal is underlined by its being the official journal of the German, Swiss, and Austrian Societies of Neuroradiology.
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