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Fluorescein-stained confocal laser endomicroscopy versus conventional frozen section for intraoperative histopathological assessment of intracranial tumors

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.In this phase II noninferiority, prospective,...

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Main Authors: Wagner, Arthur (Author) , Brielmaier, Maria Charlotte (Author) , Kampf, Charlotte (Author) , Baumgart, Lea (Author) , Aftahy, Amir Kaywan (Author) , Meyer, Hanno S (Author) , Kehl, Victoria (Author) , Höhne, Julius (Author) , Schebesch, Karl-Michael (Author) , Schmidt, Nils O (Author) , Zoubaa, Saida (Author) , Riemenschneider, Markus J (Author) , Ratliff, Miriam (Author) , Enders, Frederik (Author) , Deimling, Andreas von (Author) , Liesche-Starnecker, Friederike (Author) , Delbridge, Claire (Author) , Schlegel, Juergen (Author) , Meyer, Bernhard (Author) , Gempt, Jens (Author)
Format: Article (Journal)
Language:English
Published: May 2024
In: Neuro-Oncology
Year: 2024, Volume: 26, Issue: 5, Pages: 922-932
ISSN:1523-5866
DOI:10.1093/neuonc/noae006
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/neuonc/noae006
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Author Notes:Arthur Wagner, Maria Charlotte Brielmaier, Charlotte Kampf, Lea Baumgart, Amir Kaywan Aftahy, Hanno S. Meyer, Victoria Kehl, Julius Höhne, Karl-Michael Schebesch, Nils O. Schmidt, Saida Zoubaa, Markus J. Riemenschneider, Miriam Ratliff, Frederik Enders, Andreas von Deimling, Friederike Liesche-Starnecker, Claire Delbridge, Juergen Schlegel, Bernhard Meyer, and Jens Gempt
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Summary: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.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.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).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 Description:Veröffentlicht: 18. Januar 2024
Gesehen am 20.06.2024
Physical Description:Online Resource
ISSN:1523-5866
DOI:10.1093/neuonc/noae006

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