Abstract B001: Impedance based biomarker for “smart ROSE” pancreatic cancer detection: Initial results from an ongoing clinical trial with nsCanary
Authors: Dibennardo Federica , Guidetti Martina , Fidaner Onur , Gehrke Daniel S. , Ceres Donato , John Margaret C. , Bovalis Constantine H. , Raijman Isaac , Bogdanowicz Les 
Published: January 2024

Pancreatic cancer (PC) accounts for half a million new cases and 4.7% of cancer-related deaths globally in 2020. Endoscopic ultrasound (EUS) guided fine needle biopsies (FNB) are the current standard for confirming suspicious lesions, although their diagnostic accuracy remains below 70% with a non-diagnostic rate of the first procedure as high as 40%. Rapid on-site evaluation (ROSE) was introduced to improve diagnostic accuracy via on-site pathology assessment. However, ROSE availability is often limited due to resource constraints. NovaScan has developed the nsCanary, a ”smart ROSE” device, which uses a bioimpedance spectroscopy biomarker based on the Cole Relaxation Frequency (CRF) to detect cancer in biopsy samples in real-time and on-site. The aim of this study is to present initial results from a clinical trial that validates the nsCanary’s ability to detect PC in biopsy samples. Data were collected with the nsCanary device in an IRB approved double-blind study including a cohort of 44 patients (20 males, 24 females; average age of 63 years; 66% White, 22% African American, 12% Hispanic) undergoing EUS procedures with FNB sampling for suspected PC at the Texas International Endoscopy Center in Houston, TX. The nsCanary is a small desktop instrument that performs spectral bioimpedance analysis to extract the CRF based biomarker in less than 30 seconds without altering the biopsied tissue. A touch panel user interface allows for the user to input information and start the measurement. Obtained biopsy samples were flushed in a disposable strainer in order to drain any excess fluid. A circular disposable electrode, consisting of an interdigitated array with alternating polarities was placed in contact with the sample to perform measurements of complex bioimpedance in the 1 kHz - 10 MHz frequency range. The design of the electrode allows it to sense the signal from samples as small as FNB cores. Samples with CRF value below 1 MHz for every scan were considered noncancerous. Samples with at least one CRF value above 1MHz or absence of CRF reading (i.e., CRF out of range) were considered cancerous. PC assessment provided by nsCanary was validated against histopathology outcomes for each biopsy sample. Pathology results indicated that out of the cancerous lesions observed, there were 7 cases of pancreatic adenocarcinoma, 2 cases of invasive adenocarcinoma, 1 case of ductal adenocarcinoma, and 1 case of metastatic renal cell carcinoma. Findings showed a sensitivity of 81.8%, specificity of 84.8%, PPV of 64.3% and NPV of 93.3% for a total of n=44 patients. The device is low cost, portable, and can be used in the surgical suite without interfering with the standard workflow or affecting the sample for following pathological assessment. The implementation of the nsCanary device into the clinic will adjunctively support the decision-making process by providing immediate feedback on cancer detection and sample adequacy. This will enable endoscopists to diagnose PC on the first biopsy procedure, ultimately facilitating prompt treatment of patients.

Citation Format: Federica Dibennardo, Martina Guidetti, Onur Fidaner, Daniel S. Gehrke, Donato Ceres, Margaret C. John, Constantine H. Bovalis, Isaac Raijman, Les Bogdanowicz. Impedance based biomarker for “smart ROSE” pancreatic cancer detection: Initial results from an ongoing clinical trial with nsCanary [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Pancreatic Cancer; 2023 Sep 27-30; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(2 Suppl):Abstract nr B001.