As Seno Medical, an emerging medical imaging company based in San Antonio, TX, 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 Opto-acoustic 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 Opto-acoustic 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.
|Grayscale image on left is an oval shaped mass probably benign assigned BI-RADS 3 false negative, that was upgraded to BI-RADS 4B true positive cancer (TNBC), based on OA imaging findings on the right of additional deoxygenated vessels in and around the mass.|
Results from these studies were among the evidence that led to FDA Premarket Approval (PMA) 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.
One of the critical factors in using OA/US technology is equipping physicians with the tools and knowledge to interpret results from the system accurately and consistently. Over last three years, the ACR CRI and Seno have collaborated to develop an educational curriculum for this new imaging modality to identify key questions and best practices for members of the radiology community. An experienced CRI team served as the Imaging Core Lab for the company’s PMA study, acting as a central reading hub for images captured by the Imagio at trial sites for use in an independent reader study.
The CRI also studied the technology platform and provided Seno with guidance on best educational and training practices for the Imagio from a user’s perspective, including how to use the system, how to interpret the images and how to use data to support decisions. The resulting training/certification program will launch in the coming months as Seno’s Imagio system becomes commercially available.
“The CRI played a critical role in helping us prepare the market for this new imaging modality,” commented Thomas Stavros, MD, FACR, a key breast ultrasound thought leader and Chief Medical Officer at Seno. “The team at CRI provided us with highly valuable knowledge and insight that will help us better educate and train users and deliver an effective tool to the radiology community.”
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The ACR Center for Research and Innovation™ (CRI) supports, designs and manages research studies that aim to translate new evidence into clinical practice. We serve as a partner and a resource for ACR members, academia and industry on clinical trial design and management, and on precision diagnostics and treatment. We design artificial intelligence algorithms, and use new knowledge derived from AI and other data-driven methods to inform research, practice and reimbursement.
Seno Medical Instruments, Inc. is a San Antonio, TX-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.