Abstract

In this multi-center, assessor-blinded pilot study, the diagnostic efficacy of cCeLL-Ex vivo, a second-generation confocal laser endomicroscopy (CLE), was compared against the gold standard frozen section analysis for intraoperative brain tumor diagnosis. The study was conducted across three tertiary medical institutions in the Republic of Korea. Biopsy samples from newly diagnosed brain tumor patients were categorized based on location and divided for permanent section analysis, frozen section analysis, and cCeLL-Ex vivo imaging. Of the 74 samples from 55 patients, the majority were from the tumor core (74.3%). cCeLL-Ex vivo exhibited a relatively higher diagnostic accuracy (89.2%) than frozen section analysis (86.5%), with both methods showing a sensitivity of 92.2%. cCeLL-Ex vivo also demonstrated higher specificity (70% vs. 50%), positive predictive value (PPV) (95.2% vs. 92.2%), and negative predictive value (NPV) (58.3% vs. 50%). Furthermore, the time from sample preparation to diagnosis was notably shorter with cCeLL-Ex vivo (13 min 17 s) compared to frozen section analysis (28 min 28 s) (p-value < 0.005). These findings underscore cCeLL-Ex vivo's potential as a supplementary tool for intraoperative brain tumor diagnosis, with future studies anticipated to further validate its clinical utility.

Details

Title
A prospective multicenter assessor blinded pilot study using confocal laser endomicroscopy for intraoperative brain tumor diagnosis
Author
Byun, Yoon Hwan 1 ; Won, Jae-Kyung 2 ; Hong, Duk Hyun 3 ; Kang, Ho 4 ; Kim, Jang Hun 3 ; Yu, Mi Ok 3 ; Kim, Min-Sung 1 ; Kim, Yong Hwy 1 ; Park, Kyung-Jae 3 ; Jeong, Min-Jae 5 ; Hwang, Kyungmin 5 ; Kong, Doo-Sik 6 ; Park, Chul-Kee 1 ; Kang, Shin-Hyuk 3 

 Seoul National University Hospital, Seoul National University College of Medicine, Department of Neurosurgery, Seoul, Republic of Korea (GRID:grid.31501.36) (ISNI:0000 0004 0470 5905) 
 Seoul National University Hospital, Seoul National University College of Medicine, Department of Pathology, Seoul, Republic of Korea (GRID:grid.31501.36) (ISNI:0000 0004 0470 5905) 
 Korea University Hospital, Korea University College of Medicine, Department of Neurosurgery, Seoul, Republic of Korea (GRID:grid.411134.2) (ISNI:0000 0004 0474 0479) 
 Seoul National University Bundang Hospital, Department of Neurosurgery, Gyeonggi-Do, Republic of Korea (GRID:grid.412480.b) (ISNI:0000 0004 0647 3378) 
 VPIX Medical Inc, Daejeon, Republic of Korea (GRID:grid.411134.2) 
 Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Neurosurgery, Seoul, Republic of Korea (GRID:grid.264381.a) (ISNI:0000 0001 2181 989X) 
Pages
6784
Publication year
2024
Publication date
2024
Publisher
Nature Publishing Group
e-ISSN
20452322
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2972997226
Copyright
© The Author(s) 2024. corrected publication 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.