Abramov Irakliy, Park Marian T, Belykh Evgenii, Dru Alexander B, Xu Yuan, Gooldy Timothy C, Scherschinski Lea, Farber S Harrison, Little Andrew S, Porter Randall W, Smith Kris A, Lawton Michael T, Eschbacher Jennifer M, Preul Mark C
1The Loyal and Edith Davis Neurosurgical Research Laboratory, Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix.
2Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix.
J Neurosurg. 2022 Jul 8;138(3):587-597. doi: 10.3171/2022.5.JNS2282. Print 2023 Mar 1.
The authors evaluated the feasibility of using the first clinical-grade confocal laser endomicroscopy (CLE) system using fluorescein sodium for intraoperative in vivo imaging of brain tumors.
A CLE system cleared by the FDA was used in 30 prospectively enrolled patients with 31 brain tumors (13 gliomas, 5 meningiomas, 6 other primary tumors, 3 metastases, and 4 reactive brain tissue). A neuropathologist classified CLE images as interpretable or noninterpretable. Images were compared with corresponding frozen and permanent histology sections, with image correlation to biopsy location using neuronavigation. The specificities and sensitivities of CLE images and frozen sections were calculated using permanent histological sections as the standard for comparison. A recently developed surgical telepathology software platform was used in 11 cases to provide real-time intraoperative consultation with a neuropathologist.
Overall, 10,713 CLE images from 335 regions of interest were acquired. The mean duration of the use of the CLE system was 7 minutes (range 3-18 minutes). Interpretable CLE images were obtained in all cases. The first interpretable image was acquired within a mean of 6 (SD 10) images and within the first 5 (SD 13) seconds of imaging; 4896 images (46%) were interpretable. Interpretable image acquisition was positively correlated with study progression, number of cases per surgeon, cumulative length of CLE time, and CLE time per case (p ≤ 0.01). The diagnostic accuracy, sensitivity, and specificity of CLE compared with frozen sections were 94%, 94%, and 100%, respectively, and the diagnostic accuracy, sensitivity, and specificity of CLE compared with permanent histological sections were 92%, 90%, and 94%, respectively. No difference was observed between lesion types for the time to first interpretable image (p = 0.35). Deeply located lesions were associated with a higher percentage of interpretable images than superficial lesions (p = 0.02). The study met the primary end points, confirming the safety and feasibility and acquisition of noninvasive digital biopsies in all cases. The study met the secondary end points for the duration of CLE use necessary to obtain interpretable images. A neuropathologist could interpret the CLE images in 29 (97%) of 30 cases.
The clinical-grade CLE system allows in vivo, intraoperative, high-resolution cellular visualization of tissue microstructure and identification of lesional tissue patterns in real time, without the need for tissue preparation.
作者评估了使用首个临床级共聚焦激光内镜显微镜（CLE）系统及荧光素钠对脑肿瘤进行术中活体成像的可行性。
采用经美国食品药品监督管理局（FDA）批准的CLE系统，对30例前瞻性入组的患有31个脑肿瘤（13例胶质瘤、5例脑膜瘤、6例其他原发性肿瘤、3例转移瘤和4例反应性脑组织）的患者进行研究。一名神经病理学家将CLE图像分类为可解读或不可解读。将图像与相应的冰冻和永久组织学切片进行比较，并使用神经导航将图像与活检部位进行关联。以永久组织学切片作为比较标准，计算CLE图像和冰冻切片的特异性和敏感性。在11例病例中使用了最近开发的手术远程病理学软件平台，以便与神经病理学家进行实时术中会诊。
总体而言，从335个感兴趣区域获取了10713张CLE图像。CLE系统的平均使用时间为7分钟（范围3 - 18分钟）。所有病例均获得了可解读的CLE图像。首张可解读图像平均在6（标准差10）张图像内且在成像的前5（标准差13）秒内获得；4896张图像（46%）可解读。可解读图像的获取与研究进展、每位外科医生的病例数、CLE总时长以及每例的CLE时长呈正相关（p≤0.01）。与冰冻切片相比，CLE的诊断准确性、敏感性和特异性分别为94%、94%和100%，与永久组织学切片相比，CLE的诊断准确性、敏感性和特异性分别为92%、90%和94%。不同病变类型在首张可解读图像的获取时间上未观察到差异（p = 0.35）。与浅表病变相比，深部病变的可解读图像百分比更高（p = 0.02）。该研究达到了主要终点，证实了其安全性和可行性，并在所有病例中获取了无创数字活检。该研究也达到了获取可解读图像所需的CLE使用时长这一次要终点。30例病例中有29例（97%）的CLE图像能被神经病理学家解读。
临床级CLE系统能够在无需组织制备的情况下，对组织微观结构进行活体、术中、高分辨率的细胞可视化，并实时识别病变组织模式。
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