Patient Enrollment Begins in AI-Based Image Analytic Tool for Lung Cancer

Invenio Imaging has recruited the first patients to participate in a multicenter U.S. pivotal study of its AI-based image analysis module for lung cancer. The ON-SITE study in bronchoscopy combines Stimulated Raman Histology with artificial intelligence to quickly detect lung cancer.

Administered in collaboration with Johnson & Johnson Enterprise Innovation Inc., the trial will be conducted at multiple centers including The University of Texas MD Anderson Cancer Center, Corewell Health, Memorial Sloan Kettering Cancer Center, and University of North Carolina at Chapel Hill.

“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,” Invenio Imaging Co-Founder/CEO Jay Trautman, Ph.D., stated. “Near real-time image analysis on the NIO Laser Imaging System completes the end-to-end solution for streamlined intraoperative histology.”
 
Lung cancer is the leading cause of U.S. cancer-related deaths. This has triggered the creation of large-scale screening programs for high-risk patients, which results in an estimated 3.1 million new primary lung nodules identified annually. Despite major sector investment in minimally-invasive biopsy technology, obtaining adequate tissue for biomarker and treatment determination remains a challenge, according to Invenio Imaging. For this reason, bronchoscopy guidelines recommend rapid-on-site tissue evaluation (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,” said Jason Akulian, M.D., director of Interventional Pulmonlogy at UNC. “We are excited by the NIO’s potential to extend the benefits of ROSE to the proceduralist when the service is not available.”
 
The NIO Laser Imaging System allows clinicians to rapidly image fresh tissue biopsies in the treatment room. Sample preparation does not require staining or sectioning and can be performed by the existing OR-staff. NIO Slides are also designed to allow clinicians to retrieve the sample for downstream analysis. NIO images are natively digital and can be shared in near real-time. The ON-SITE study aims to develop and validate an AI-based image analysis module for the NIO Laser Imaging System that is intended to help physicians detect cancer in bronchoscopic lung biopsies in situations where ROSE is not available for the sample type.
 
“Artificial intelligence 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/benefit profile, and personalized treatments,” said Gustavo Cumbo-Nacheli, M.D., pulmonologist at Corewell Health and an ON-SITE principal investigator.
 
Invenio Imaging is an emerging, privately held medical device company based in Santa Clara, Calif., that aims to advance cancer care by combining intraoperative fresh tissue imaging and artificial intelligence. The NIO Laser Imaging System is U.S. Food and Drug Administration-registered and CE-marked and has been used in more than 10,000 procedures across neurosurgery, bronchoscopy, urology, and endoscopy. Invenio Imaging’s first AI product, the NIO Glioma Reveal, has received CE mark and is available for clinical use in Europe. The AI product for lung cancer that is the subject of the ON-SITE study has not been approved for clinical use.