Invenio Imaging announced that it has begun enrolling patients in a pivotal study of its artificial intelligence (AI)-based image analysis module for lung cancer.
The On-Site study is a multicenter study in bronchoscopy combining stimulated Raman histology with AI for rapid lung cancer detection; it will be conducted at centers that include the University of Texas MD Anderson Cancer Center, Corewell Health, the Memorial Sloan Kettering Cancer Center, and the University of North Carolina (UNC) at Chapel Hill. The study is being conducted in collaboration with Johnson & Johnson Enterprise Innovation, Invenio said in a statement.
"Enrolling the first patient in the ON-SITE study is an important milestone for Invenio, as we aim to develop the first FDA-cleared AI to identify cell/tissue morphology suspicious for cancer in lung biopsies," Jay Trautman, PhD, co-founder and CEO of Invenio Imaging, said.
The On-Site study aims to develop and validate an AI-based image analysis module for Invenio's NIO Laser Imaging System. The system is designed to assist physicians in detecting cancer in bronchoscopic lung biopsies in situations where rapid onsite tissue evaluation (ROSE) is not available for the sample type.
As obtaining adequate tissue for biomarker and treatment determination remains difficult in lung cancer screening, bronchoscopy guidelines recommend ROSE for lung biopsies.
"ROSE requires that a cytologist or highly trained cytotechnician be physically present in the procedure room, and thus it is not available at many centers performing lung biopsy due to resource limitations," Dr. Jason Akulian, director of interventional pulmonology at UNC, said. "We are excited by the NIO's potential to extend the benefits of ROSE to the proceduralist when the service is not available."
The study is being supported by the National Cancer Institute of the U.S. National Institutes of Health under award No. 1R44CA281581-01.
