California-based diagnostic imaging firm, Invenio Imaging, has announced that it has completed enrolment for a pivotal trial of its artificial intelligence (AI) driven software designed to identify lung cancer in a bid to become its first lung cancer AI imaging software cleared by the US Food and Drug Administration (FDA).
Coming as part of a collaboration with pharmaceutical giant Johnson & Johnson, the multi-centre trial aims to test Invenio’s NIO Laser Imaging System, designed to allow for much more detailed lung imaging by speeding up the production and analysis of the digital images it produces.
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The trial dubbed the ON-SITE study, will be carried out across two universities in Texas and North Carolina. The study aims to develop and validate an AI-based image analysis module for the NIO system that is intended to assist clinicians in the detection of cancer in bronchoscopic lung biopsies. Typically bronchoscopy guidelines recommend rapid-on-site tissue evaluation (ROSE) for lung biopsies. The NIO system is designed to fill in the gaps where ROSE is not available due to staff limitations.
Dr. Jason Akulian, director of Interventional Pulmonology at the University of North Carolina, said: “ROSE requires that a cytologist or highly trained cytotechnician be physically present in the procedure room, and thus it is not available at many centres performing lung biopsy due to resource limitations.
“We are excited by the NIO’s potential to extend the benefits of ROSE to the proceduralist when the service is not available.”
Additionally, Invenio says that the device allows for greater flexibility from hospital staff allowing them to carry out rapid imaging of fresh tissue biopsies where it would not have initially been available.The company says that with the NIO system, sample preparation does not require staining or sectioning and can be performed by existing OR staff.
Gustavo Cumbo-Nacheli, principal investigator for the ON-SITE study, said: “AI aiding healthcare may seem utopic, but the future is coming. While still investigational, the promise of fast, in-room, accurate identification of tissue that is suspicious for cancer has the potential to ultimately lead to improved outcomes, a beneficial cost to benefit profile, and personalised treatments.”
Elsewhere in the field of lung cancer imaging, Galvanize Therapeutics has announced the completion of patient enrolment in the AFFINITY study assessing the Aliya pulsed electric field (PEF) system in treating late-stage non-small cell lung cancer. At the same time, Qure.ai has obtained Health Canada’s Class III medical device licence for its suite of medical imaging AI solutions.
