French microsensing technology pioneer, Sensome has announced that the first eight patients have been enrolled in the first-in-human INSPECT study of its novel microsensor technology. The aim is to instantly detect cancerous tissue during transbronchial biopsy of endobronchial tumors and peripheral lung nodules.
Background
Sensome’s unique technology is based on electrical impedance spectroscopy. The principle is that cancer cells produce different impedance values than healthy tissue. Indeed we’ve previously covered news of devices that use what is fundamentally the same science, as seen here.
The Sensome system measures the characteristics of tissue in 360° surrounding the sensor. The company’s proprietary predictive algorithms analyse and characterise these biological tissues in real-time. Sensome’s miniaturized sensor technology can be incorporated in a device that can be introduced through a biopsy needle into a lesion. The company is developing its technology to instantly confirm whether or not the tissue is cancerous. This means operator can go on to successfully complete the biopsy. Importantly the system seamlessly integrates with the current transbronchial biopsy workflow.
Sensome technology
Sensome designed its technology to quickly confirm placement of a biopsy needle within a tumor. Furthermore it does so without reliance on additional imaging modalities. This novel tool-in-lesion system integrates the company’s impedance tissue microsensor. Sensome designed it specifically to guide the bronchoscopist in precisely locating the biopsy site. The ultimate goal is to reduce delays in the diagnosis and treatment of lung cancer.
The INSPECT study is a first-in-human, multi-center, single-arm study. It aims to evaluate the ability of Sensome’s system to differentiate between healthy and diseased lung lesion tissue.
Investigator comments
Associate Professor David Fielding, Director of Thoracic Medicine at Royal Brisbane and Women’s Hospital in Australia. He is principal investigator of the INSPECT study and performed the first cases. He says; “Lung cancer is the most common and deadly cancer in the world, killing almost two million people globally each year. With the growth of lung cancer screening, it is urgent that we improve the efficiency of diagnosing patients with lung cancer and getting them to treatment. This begins with how we perform biopsies. The earlier we can successfully biopsy and diagnose the disease, the better the outcome for the patient.”
Amir Hanna, MD, coordinating investigator of the INSPECT study at Lannelongue Hospital, France comments; “Lung cancer is challenging to diagnose today, with an up to 58% failure rate in obtaining a successful biopsy. This causes repeat procedures and treatment delays. An easy-to-use, in situ tool-in-lesion system that can make us better and more successful bronchoscopists would be a paradigm shift in the biopsy of peripheral lung nodules.”
Sensome comments
Franz Bozsak is CEO and co-founder of Sensome. He states; “We are excited to be expanding the indications for our microsensor technology platform into interventional oncology with initiation of this clinical study, which follows our successful initial clinical work in ischemic stroke and peripheral artery disease. The prospect of being able to positively affect the trajectory of lung cancer patients with our technology is an exciting one.” “The potential for our microsensor platform is tremendous, as the ability to instantly analyze tissue intra-operatively could transform the success and economics of innumerable minimally invasive procedures throughout the body.”
The Sensome tumor confirmation technology is an investigational device. It is not approved for commercial use in the U.S or any other jurisdiction.
Source: Sensome
published: September 12, 2024 in: AI, Clinical Studies/Trials, Diagnostics, News, Oncology, Technology, Thoracic/Respiratory