As Seno Medical, an emerging medical imaging company based in San Antonio, Texas, developed their Imagio® opto-acoustic/ultrasound (OA/US) imaging technology, company leaders knew they would need an experienced Imaging Core Lab to support the pivotal trial, and to coordinate and contribute to a training program to educate users on this new category of imaging modality. They chose the American College of Radiology® (ACR®) Center for Research and Innovation™ (CRI).
For Seno Medical, the ACR conducted two clinical research projects to provide evidence to the United States Food and Drug Administration (FDA) for the approval process of the company’s OA/US system, Imagio® Breast Imaging System, which combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a blood map in and around breast masses, while the ultrasound provides a traditional anatomical image.
• The first reader study: Imagio Feasibility Multi-Reader, Multi-Case Study of Optoacoustic Images versus Imagio Ultrasound to Guide Decision to Biopsy, involved breast cancer screening and diagnostic imaging from 155 women, read by 10 breast imaging radiologists recruited from ACR membership as on-site readers.
• The second reader study: Imagio Pivotal Multi-Reader, Multi-Case Study of Optoacoustic Images versus Imagio Ultrasound to Guide Decision to Biopsy, involved breast cancer screening and diagnostic imaging from 480 women read by 15 primary breast imaging radiologists recruited from ACR membership as on-site readers.
Results from these studies were among the evidence that led to FDA PMA approval for use of the Imagio Breast Imaging System in the United States in January 2021. Through the appearance or absence of two hallmark indicators of cancer, angiogenesis and deoxygenation, the FDA-approved platform delivers an effective tool to help radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities — without use of ionizing radiation (X-rays) or contrast agents. The device is now in testing to assess the response to cancer therapy.
“This collaboration is a prime example of how the ACR CRI can help many stakeholders translate innovation that leads to new evidence into clinical practice,” said ACR Chief Research Officer Etta D. Pisano, MD, FACR. The Imagio system also includes artificial intelligence with machine learning called the SenoGram™ a clinical physician decision support tool which helps to objectively and precisely assign a likelihood of malignancy. The SenoGram, along with training and certification, help radiologists make the transition from reading ultrasound alone to OA/US Imaging. The Imagio Breast Imaging System is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.
