Optoacoustic-Ultrasound Fusion Could Potentially Eliminate the Need for a Breast Biopsy and Track Early Response to Treatment

A new imaging modality may be an effective approach in reducing the need for biopsy in patients with benign but suspicious-appearing breast masses on standard diagnostic breast ultrasound.

Seno Medical Instruments, Inc. (San Antonio, TX, USA), the company that developed optoacoustic (OA) imaging into a tool called Imagio to optimize the diagnosis of breast cancer, reported that two analyses of outcomes from a US feasibility study of its investigational Imagio breast imaging device were presented at the annual meeting of the European Congress of Radiology (ECR) 2014, held in Vienna, Austria in March 2014.


Analysis of this data suggests that information from Imagio may have the potential to achieve clinically-meaningful sensitivity and specificity for breast cancer beyond those achievable with conventional, standalone diagnostic-ultrasound systems. This will be validated in the ongoing US pivotal study, which has already enrolled more than half of the 2,000 study participant target.

“We are encouraged by these findings, which demonstrate the biopsy-sparing potential of Imagio,” said Thomas Stavros, MD, FACR, FSRU, FRANZCR, medical director, Seno Medical Instruments. “While surgical and core needle biopsies are considered the gold standard for breast cancer diagnosis, biopsies are the most expensive part of the diagnostic process and over 80% of US biopsies are negative. Imagio has the potential to contribute to the way that breast cancer is diagnosed and to optimize the decision to biopsy.”

The second statistical analysis is of predefined histopathology findings pertinent to the specific features of benign and malignant lesions. These data were captured in the Imagio optoacoustic images during the study, suggesting that the technology could possibly provide additional data that could help clinicians grade the aggressiveness of cancerous breast tumors during the imaging phase of a woman’s diagnostic work-up, which will also be verified in the ongoing pivotal study.

Separate analysis of the feasibility data revealed that OA findings could potentially compare with molecular subtypes of breast cancer. “If confirmed in a larger series of breast cancer patients, this analysis suggests that OA findings might be useful in differentiating and monitoring early response to medical oncologic treatments,” said lead biostatistician Philip Lavin, PhD, FASA, FRAPS, who is a consultant to Seno Medical Instruments. “Our ongoing pivotal study will continue to elucidate the potential Imagio may have in both classifying breast masses and determining molecular subtypes.”

Imagio fuses an imaging technology based on light-in and sound-out called optoacoustics with traditional ultrasound. The optoacoustic images provide a unique blood map in and around suspicious breast masses. Dissimilar to other imaging techniques, Imagio does not expose patients to potentially harmful ionizing radiation or injectable contrast agents.

Each year in the United States, 1.7 million women undergo core needle or surgical breast biopsies after a suspicious mass is discovered with the use of breast imaging or self-exams. However, more than 80% of these biopsies reveal benign pathology.

Seno Medical Instruments’ Imagio breast imaging system uses optoacoustic technology co-registered with ultrasound to generate functional and anatomic images of the breast. The optoacoustic images provide a distinctive blood map around suspicious breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of the two key characteristic indicators of cancer--angiogenesis and deoxygenation—the company believes that Imagio images will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities, without exposing patients to potentially harmful ionizing radiation (X-rays) or contrast agents. Seno's platform technology may also address other disease applications.

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