Wagner, Arthur and Brielmaier, Maria Charlotte and Kampf, Charlotte and Baumgart, Lea and Aftahy, Amir Kaywan and Meyer, Hanno S. and Kehl, Victoria and Hoehne, Julius and Schebesch, Karl-Michael and Schmidt, Nils O. and Zoubaa, Saida and Riemenschneider, Markus J. and Ratliff, Miriam and Enders, Frederik and von Deimling, Andreas and Liesche-Starnecker, Friederike and Delbridge, Claire and Schlegel, Juergen and Meyer, Bernhard and Gempt, Jens (2024) Fluorescein-stained confocal laser endomicroscopy versus conventional frozen section for intraoperative histopathological assessment of intracranial tumors. NEURO-ONCOLOGY, 26 (5). pp. 922-932. ISSN 1522-8517, 1523-5866
Full text not available from this repository. (Request a copy)Abstract
Background The aim of this clinical trial was to compare Fluorescein-stained intraoperative confocal laser endomicroscopy (CLE) of intracranial lesions and evaluation by a neuropathologist with routine intraoperative frozen section (FS) assessment by neuropathology. Methods In this phase II noninferiority, prospective, multicenter, nonrandomized, off-label clinical trial (EudraCT: 2019-004512-58), patients above the age of 18 years with any intracranial lesion scheduled for elective resection were included. The diagnostic accuracies of both CLE and FS referenced with the final histopathological diagnosis were statistically compared in a noninferiority analysis, representing the primary endpoint. Secondary endpoints included the safety of the technique and time expedited for CLE and FS. Results A total of 210 patients were included by 3 participating sites between November 2020 and June 2022. Most common entities were high-grade gliomas (37.9%), metastases (24.1%), and meningiomas (22.7%). A total of 6 serious adverse events in 4 (2%) patients were recorded. For the primary endpoint, the diagnostic accuracy for CLE was inferior with 0.87 versus 0.91 for FS, resulting in a difference of 0.04 (95% confidence interval -0.10; 0.02; P = .367). The median time expedited until intraoperative diagnosis was 3 minutes for CLE and 27 minutes for FS, with a mean difference of 27.5 minutes (standard deviation 14.5; P < .001). Conclusions CLE allowed for a safe and time-effective intraoperative histological diagnosis with a diagnostic accuracy of 87% across all intracranial entities included. The technique achieved histological assessments in real time with a 10-fold reduction of processing time compared to FS, which may invariably impact surgical strategy on the fly.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | NERVOUS-SYSTEM TUMORS; GUIDED SURGERY; EANO GUIDELINE; GLIOMAS; EXPERIENCE; MANAGEMENT; DIAGNOSIS; RESECTION; ACCURACY; brain tumor histology; confocal laser endomicroscopy; frozen section; intraoperative diagnosis; telepathology |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurochirurgie Medicine > Abteilung für Neuropathologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 27 Jan 2026 10:17 |
| Last Modified: | 27 Jan 2026 10:17 |
| URI: | https://pred.uni-regensburg.de/id/eprint/64777 |
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