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Original Article   

Journal of Neurosurgical Sciences 2022 Sep 16

DOI: 10.23736/S0390-5616.22.05906-9

Copyright © 2022 EDIZIONI MINERVA MEDICA

language: English

A new study protocol for in vivo assessment of tumor diagnosis and microscopic tumor infiltration at the resection cavity in Central Nervous System tumors by a new miniature confocal endomicroscope (CONVIVO system)

Francesco RESTELLI 1, Elio MAZZAPICCHI 1, Bianca POLLO 2, Jacopo FALCO 1, Giulio BONOMO 1, Emanuele LA CORTE 1, 3, Morgan BROGGI 1, Marco SCHIARITI 1, Francesco DI MECO 1, 4, Paolo FERROLI 1, Irene TRAMACERE 5, Francesco ACERBI 1, 6

1 Department of Neurosurgery, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy; 2 Neuropathology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy; 3 Alma Mater Studiorum University of Bologna, Bologna, Italy; 4 Department of Oncology and Hematology-Oncology, University of Milan, Italy; 5 Department of Research and Clinical Development, Scientific Directorate, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy; 6 Microsurgical Experimental Laboratory, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy


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BACKGROUND: Confocal laser technology has been recently suggested as a promising method to obtain near real-time intraoperative histological data. We recently demonstrated the accuracy of a newly designed confocal endomiscroscope (CONVIVO) in offering an intraoperative diagnosis during high-grade gliomas (HGGs) removal in an ex vivo study. With this work we aim to perform a standardized, prospective and blinded-to-histological section study for evaluating the potentiality of CONVIVO in offering in vivo data regarding histological diagnosis and presence of tumor at margins during resection of central nervous system (CNS) tumors.
METHODS: This prospective, observational, standardized, blinded-to-histological section, clinical trial was approved by the institutional review board in Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan and is expected to last 24 months. 75 patients will be included, with at least 53 of them being HGGs based on the statistical sample size calculation. Main objectives will be the assessing of the concordance of tumor diagnoses between CONVIVO images and frozen section at the center of all tumor subtypes and the evaluation of the accuracy of CONVIVO in the identification of tumor tissue at the margins, compared to standard histology. For this purpose, “virtual biopsies” and physical biopsies will be performed directly on patient tumor tissue and surrounding brain parenchima during tumor resection, comparing the results of CONVIVO analysis and frozen and histological sections.
RESULTS: Despite promising preliminary data on ex vivo usefulness of CLE machines are emerging in literature, still few studies are available when looking at in vivo potentiality of CONVIVO. At this regard, this study will be the first work where a standardized, prospective, and blinded-to-histological section CONVIVO analysis will be performed in an in vivo setting in neuro-oncological surgery.
CONCLUSIONS: We hypothesize that this new technique may have a role in offering data regarding presence of tumor tissue, eventually giving an intraoperative diagnosis in neurooncological surgery, rendering more fluid the decision-making process in the operating room. Furthermore, the result of this study will provide a solid base for further expanding the clinical applications of confocal machines in neurosurgery.


KEY WORDS: Confocal imaging; Sodium fluorescein; CONVIVO; In vivo

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