FDA Grants Premarket Approval to Diagnostic Breast Cancer Imaging Technology

The FDA’s Center for Devices and Radiological Health has granted premarket approval (PMA) to diagnostic breast cancer imaging technology developed by Seno Medical Instruments to assist in the differentiation between benign and malignant breast lesions in patients.¹

By using noninvasive poto-acoustic ultrasound technology, the Imagio Breast Imaging System is able to produce data on suspicious lesions in real time; as such, the information can be utilized to both describe and masses that may potentially require more invasive diagnostic evaluation and discern them from those that do not.

Specifically, the system has been indicated for use by trained and qualified healthcare providers who will utilize this technology to examine both palpable and nonpalpable breast abnormalities in adult patients who have been referred for a diagnostic breast imaging work-up after there has been clinical presentation or other examination such as a screening mammography has been performed.

“Optimizing the diagnosis of breast masses requires a combination of very high sensitivity (≥98%) while simultaneously maximizing specificity and minimizing false positives and biopsies of benign masses,” A. Thomas Stavros, MD, FACR, FSBI, stated in a press release. “Other modalities have reported improvements in specificity, but these have often come at the expense of the desired high ≥98% sensitivity.”

The imaging system combines laser optics with grayscale ultrasound to produce fused functional and anatomical breast imaging. The images offer a “unique blood map” both inside of and around the lesions in the breast, and the ultrasound produces a traditional anatomical image.

Because the imaging system reveals angiogenesis and deoxygenation, 2 important indicators of disease, it is believed that the technology will serve as a stronger tool for radiologists compared with other traditional imaging modalities to differentiate benign lesions from malignant ones. Notably, the system should be able to do this without exposing patients to ionizing radiation or contrast drugs.

The company also provides an AI physician decision support tool with the imaging system, referred to as the SenoGram, to help interpret the new images in a way that radiologists will be able to transition from an ultrasound-only approach to the technology.

Stavros added that findings from the PMA study demonstrated that the system was able to improve specificity at a fixed sensitivity of 98%, which is part of the receiving operating characteristic curve where the decision of whether a mass should be biopsied is made.

The imaging system is being evaluated in a couple of clinical trials. In the prospective, controlled, multicenter PIONEER-0 study (NCT01943916), investigators are evaluating gray scale ultrasound compared with the novel imaging system to visualize suspicious masses.² The Imagio gray scale and OA image sets will be done for each enrolled lesion and they will be passed to an Imaging Core Lab to undergo processing. From there, they will be sent to a set of Independent Readers who will read the gray-scale images and compare them with the images produced by the Imagio system.

In the post-market, nonrandomized, multicenter MAESTRO trial (NCT02364388), investigators will examine the imaging system to determine whether it is able to downgrade Breast Imaging-Reporting and Data System classification after Conventional Diagnostic Ultrasound (CDU) has been performed for both the classification and visualization of suspicious lesions before to core needle biopsy or excision.³ In this work, CDU will be performed to form a diagnosis and a decision will be made regarding biopsy.

References

1. FDA approves Seno Medical’s ground-breaking breast cancer diagnostic technology. News release. Seno Medical Instruments. January 19, 2021. Accessed January 19, 2021. http://bit.ly/3bWSzGq.
2. The PIONEER-0 study of the Imagio Breast Imaging System. ClinicalTrials.gov. Updated January 18, 2018. Accessed January 19, 2021. https://clinicaltrials.gov/ct2/show/NCT01943916.
3. IMAging with Opto-acoustic to downgrade BI-RADS classification relative tO other diagnostic methodologies (MAESTRO) (MAESTRO). ClinicalTrials.gov. Updated April 6, 2020. Accessed January 19, 2021. https://clinicaltrials.gov/ct2/show/NCT02364388.