Noninvasive pulmonary nodule characterization using transcutaneous bioconductance Preliminary results of an observational study

We sought to assess the use of an electro pulmonary nodule (EPN) scanner (FreshMedx, Salt Lake City, UT) in the noninvasive characterization of pulmonary nodules using transcutaneous bioconductance. Monocentric prospective study including patients with a pulmonary nodule identified on a chest computed tomography scan. Study protocol approved by the institutional review board and written consent was obtained for every patient. 32 patients (12 females and 20 males), average age 65 years, and average lesion size 33.1mm (range: 9-123mm). Data collection by a trained physician, 62 skin surface measurements on the chest, arms, and hands bilaterally. Results were anonymized and mailed to a central data center for analysis and compared to histopathology. Pathology results obtained by percutaneous biopsy (n = 14), surgical biopsy (n=1), or surgical resection (n=17) showed 29 malignant lesions (adenocarcinoma n=21, squamous cell carcinoma n=5, typical carcinoid n=1, metastasis n=2), and 3 benign lesions (necrotic granuloma n=1, no malignant cells on biopsy n=2). EPN scanner results had a specificity of 66.67% (95% confidence interval [CI] 0.09-0.99), sensitivity 72.41% (95% CI 0.53-0.87), positive predictive value 95.45% (95% CI 0.81-0.99), and a negative predictive value 20.00% (95% CI 0.08-0.40). This pilot study showed a high positive predictive value of the EPN scanner, allowing aggressive management of lung nodules characterized as malignant. The low negative predictive value warrants further investigation of nodules that are characterized as benign.