Introduction
Pancreatic cancer (PC) accounts for 0.5 million new cases and 4.7% of the world's cancer-related deaths in 20201,2. Endoscopic ultrasound (EUS) guided Fine Needle Biopsies (FNB) are the current standard of care for confirming suspicious lesions, however the diagnostic accuracy is reported below 70%3-5. Rapid on-site evaluation (ROSE) improves the diagnostic performances of biopsies via an on-site pathological assessment to reduce the number of needle passes, complication rates, and the need for additional procedures6. However, availability of an on-site pathologist is often not feasible. NovaScan has pioneered the use of an impedance spectroscopy biomarker for cancer detection in different tissues based on the Cole Relaxation Frequency (CRF). NovaScan has developed a ”smart ROSE” device that assesses PC presence in FNBs obtained during endoscopic procedures ex vivo, in real-time and on-site, without altering the tissue sample or affecting the workflow.
Aims & Methods
Data were collected in a double-blind, IRB approved study from a cohort of 21 patients (9 males, 12 females) undergoing EUS procedures for suspected pancreatic lesions at the Texas International Endoscopy Center. FNBs were performed with a 22 gauge biopsy from a transduodenal approach. Each biopsy sample was transferred onto a disposable strainer allowing for any excess fluid to drain. An electrode for scanning was placed onto the core samples for data collection with the "smart ROSE," a low cost, portable device that can be used in the operating room. The device measures impedance spectroscopy in the 1 kHz - 10 MHz frequency range and derives a bio impedance biomarker via custom-designed hardware. The assessment of the sample is completed in a few seconds and subsequently, the sample is flushed into a pathology jar to undergo the standard workflow for cytology. The algorithm for extracting the bioimpedance biomarker from the measurement was developed based on our previous preclinical study with transgenic (KPC) mice7; pancreas samples with a CRF biomarker below 1 MHz were considered noncancerous, while biomarker values above 1MHz or the absence of a biomarker reading were considered cancerous.
Results
PC assessment provided by nsCanary was validated against pathology outcomes for each biopsy sample. Findings showing a sensitivity of 80% and a specificity of 87.5% are reported in Table 1.
| Table 1. Confusion matrix for asessments and pathology outcomes. CA indicates cancerous outcome, NC indicates noncancerous outcome. |
| Pathology Outcome |
| CA | NC |
nsCanary
Assessment | CA | 4 | 2 |
| NC | 1 | 14
|
Conclusion
We believe the "smart ROSE" device will provide immediate feedback to the endoscopist on cancer presence and on sample adequacy. This device is intended to support the decision-making process by enabling clinicians to overcome the challenge of proving cancer presence during the first biopsy procedure, ultimately avoiding revisits and unnecessary trauma.
References
1. S. Kato and K. Honda. Use of biomarkers and imaging for early detection of pancreatic cancer. Cancers, 12(7):1965, 2020.
2. M. R. Young, N. Abrams, S. Ghosh, J. A. S. Rinaudo, G. Marquez, and S. Srivastava. Prediagnostic image data, artificial intelligence, and pancreatic cancer: a tell-tale sign to early detection. Pancreas, 49(7):882–886,2020.
3. S. Varadarajulu and M. B. Wallace. Applications of endoscopic ultrasonography in pancreatic cancer. Cancer Control, 11(1):15–22, 2004.
4. P. Michl et al. UEG position paper on pancreatic cancer. Bringing pancreatic cancer to the 21st century: Prevent, detect,and treat the disease earlier and better. UEG journal, 9(7):860–871, 2021
5. D. T. de Moura et al. Evaluation of endoscopic ultrasound fine-needle aspiration versus fine-needle biopsy and impact of rapid on-site evaluation for pancreatic masses. Endoscopy International Open, 8(06):E738–E747, 2020.
6. J. B. Klapman, R. Logrono, C. E. Dye, and I. Waxman. Clinical impact of on-site cytopathology interpretation on endoscopic ultrasound-guided fine needle aspiration. The American journal of gastroenterology, 98(6):1289–1294, 2003.
7. Bogdanowicz, Les, et al. Cole Relaxation Frequency: A Parameter for Pancreatic Cancer Detection. The American Journal of Gastroenterology 117(10S):p e24-e25, October 2022
