TY - JOUR
T1 - Electrical Impedance Analysis for Lung Cancer
T2 - A Prospective, Multicenter, Blind Validation Study
AU - Yang, Dawei
AU - Gu, Chuanjia
AU - Gu, Ye
AU - Zhang, Xiaodong
AU - Ge, Di
AU - Zhang, Yong
AU - Wang, Ningfang
AU - Zheng, Xiaoxuan
AU - Wang, Hao
AU - Yang, Li
AU - Chen, Saihua
AU - Xie, Pengfei
AU - Chen, Deng
AU - Yu, Jinming
AU - Sun, Jiayuan
AU - Bai, Chunxue
N1 - Publisher Copyright:
Copyright © 2022 Yang, Gu, Gu, Zhang, Ge, Zhang, Wang, Zheng, Wang, Yang, Chen, Xie, Chen, Yu, Sun and Bai.
PY - 2022/7/20
Y1 - 2022/7/20
N2 - Hypothesis: Patients with cancer have different impedances or conductances than patients with benign normal tissue; thus, we can apply electrical impedance analysis (EIA) to identify patients with cancer. Method: To evaluate EIA’s efficacy and safety profile in diagnosing pulmonary lesions, we conducted a prospective, multicenter study among patients with pulmonary lesions recruited from 4 clinical centers (Zhongshan Hospital Ethics Committee, Approval No. 2015-16R and 2017-035(3). They underwent EIA to obtain an Algorithm Composite Score or ‘Prolung Index,’ PI. The classification threshold of 29 was first tested in an analytical validation set of 144 patients and independently validated in a clinical validation set of 418 patients. The subject’s final diagnosis depended on histology and a 2-year follow-up. Results: In total, 418 patients completed the entire protocol for clinical validation, with 186 true positives, 145 true negatives, 52 false positives, and 35 false negatives. The sensitivity, specificity, and diagnostic yield were 84% (95% CI 79.3%-89.0%), 74% (95% CI 67.4%-79.8%), and 79% (95%CI 75.3%-83.1%), respectively, and did not differ according to age, sex, smoking history, body mass index, or lesion types. The sensitivity of small lesions was comparable to that of large lesions (p = 0.13). Four hundred eighty-four patients who underwent the analysis received a safety evaluation. No adverse events were considered to be related to the test. Conclusion: Electrical impedance analysis is a safe and efficient tool for risk stratification of pulmonary lesions, especially for patients with a suspicious lung lesion.
AB - Hypothesis: Patients with cancer have different impedances or conductances than patients with benign normal tissue; thus, we can apply electrical impedance analysis (EIA) to identify patients with cancer. Method: To evaluate EIA’s efficacy and safety profile in diagnosing pulmonary lesions, we conducted a prospective, multicenter study among patients with pulmonary lesions recruited from 4 clinical centers (Zhongshan Hospital Ethics Committee, Approval No. 2015-16R and 2017-035(3). They underwent EIA to obtain an Algorithm Composite Score or ‘Prolung Index,’ PI. The classification threshold of 29 was first tested in an analytical validation set of 144 patients and independently validated in a clinical validation set of 418 patients. The subject’s final diagnosis depended on histology and a 2-year follow-up. Results: In total, 418 patients completed the entire protocol for clinical validation, with 186 true positives, 145 true negatives, 52 false positives, and 35 false negatives. The sensitivity, specificity, and diagnostic yield were 84% (95% CI 79.3%-89.0%), 74% (95% CI 67.4%-79.8%), and 79% (95%CI 75.3%-83.1%), respectively, and did not differ according to age, sex, smoking history, body mass index, or lesion types. The sensitivity of small lesions was comparable to that of large lesions (p = 0.13). Four hundred eighty-four patients who underwent the analysis received a safety evaluation. No adverse events were considered to be related to the test. Conclusion: Electrical impedance analysis is a safe and efficient tool for risk stratification of pulmonary lesions, especially for patients with a suspicious lung lesion.
KW - diagnosis
KW - electrical impedance
KW - lung cancer
KW - prospective
KW - pulmonary nodules
UR - http://www.scopus.com/inward/record.url?scp=85135454121&partnerID=8YFLogxK
U2 - 10.3389/fonc.2022.900110
DO - 10.3389/fonc.2022.900110
M3 - Article
AN - SCOPUS:85135454121
SN - 2234-943X
VL - 12
JO - Frontiers in Oncology
JF - Frontiers in Oncology
M1 - 900110
ER -