SAN ANTONIO, Dec. 21, 2015 /PRNewswire/ -- Seno Medical Instruments, Inc., the company pioneering the development of an opto-acoustic (OA) device as a new tool to improve the process of diagnosing breast cancer, announced results of its Pilot Study portion of the PIONEER pivotal study. The pilot study demonstrated the potential of the company's Imagio breast imaging system to improve physicians' ability to accurately classify benign breast masses compared to traditional ultrasound methods. The results of the 100 subject pilot study, conducted as the initial part of a larger U.S.-based, multicenter PIONEER pivotal study of over 2,000 subjects, were presented at the annual meeting of the Radiological Society of North America (RSNA) on December 2 in Chicago, IL.
The PIONEER study is being conducted to demonstrate the ability of the Imagio OA breast imaging system to downgrade BI-RADS® (Breast Imaging-Reporting and Data System) scores. Specifically, whether masses originally scored BI-RADS (BR) 4a or 4b (in which a suspicious abnormality is discovered and a biopsy is recommended) could be downgraded to either BR 3 (probably benign, <2% likelihood of malignancy with short-interval follow-up recommended) or 2 (benign) and if masses coded BR 3 could be downgraded to 2.
Seven independent breast radiologist readers (IRs) and an expert radiologist (ER) trainer blindly assessed 102 masses from the pilot study cases using only Imagio OA images. Among these subjects, there were 75 biopsied masses (39 benign, 36 malignant). Gray-scale ultrasound images were taken with the Imagio system's conventional ultrasound immediately prior to the OA exam. These images were designated the internal ultrasound control (IUC). Later, the IRs assigned a BR score to these images.
Using OA, the IRs downgraded conventional diagnostic ultrasound findings classified BR 3 masses to BR 2 in 33% of cases, BR 4a masses to BR 2 or 3 in 53% of cases, and BR 4b masses to BR 3 or 2 in 33% of cases. Using OA, the IRs downgraded BI-RADS categories of the internal ultrasound control-classified BR 3 masses to BR 2 in 43% of cases, BR 4a to either BR 3 or 2 in 43% of cases and BR 4b masses to either BR 3 or 2 in 13% of cases. OA had 97.6% sensitivity and 44.4% specificity.
"Downgrading benign masses classified as BR 4b (moderate suspicion), 4a (low suspicion) and 3 without missing cancers is an unmet need that the Imagio OA breast imaging system can potentially help address," said Erin Neuschler, MD, Northwestern Medicine Radiologist, Assistant Professor of Radiology at the Northwestern University Feinberg School of Medicine and the Co-Principal Investigator of the PIONEER Study. "If these pilot findings are verified after the completion of the multicenter PIONEER Study, we will have confirmation that the Imagio OA breast imaging system could help women not only avoid biopsy procedures but also multiple short interval follow-up ultrasound exams over two years."
The Imagio OA breast imaging system was designed to identify the two functional hallmarks of cancer: the presence of abnormal blood vessels (tumor angiogenesis) and the relative reduction in oxygen content of blood that occurs in cancer compared to benign masses and normal tissues. The technology used by the Imagio system is non-invasive and does not require patient exposure to contrast agents, ionizing radiation (x-ray) or radio-isotopes, which are required for other modalities that are capable of functional imaging, including magnetic resonance imaging (MRI) or positron emission tomography (PET).
"Diagnostic specificity remains disappointingly low for diagnostic morphologic imaging modalities and reading algorithms that have been optimized to achieve very high sensitivity at the expense of low specificity – which, of course, results in many false positives and generates a high percentage of negative biopsies," said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director of Seno Medical Instruments. "These encouraging results indicate that Imagio can potentially offer physicians a tool to more accurately identify women who do not have breast cancer, and thus, who do not need to undergo invasive and expensive biopsy procedures and/or the stress of undergoing multiple follow-up exams over a two year period, depending upon whether the OA-based downgrade is to BI-RADS category 2 or 3. Reducing false positives and the number of negative biopsies, two of the main perceived and well-publicized 'harms' of breast cancer screening, may help defuse some of the criticisms being put forth by the anti-breast cancer screening movement. As breast radiologists, we can and we should do better in diminishing false positives and reducing negative biopsies. OA is a functional and morphologic diagnostic tool that has the potential to help us achieve better specificity without sacrificing sensitivity, diminish the percentage of negative biopsies generated by breast cancer screening, and to reduce the perceived 'harms' of breast cancer screening."
The RSNA annual meeting is the premiere conference in the world for radiology and medical imaging leaders. It is an international forum of peer-reviewed research, state-of-the-art technology and education for radiologists, radiation oncologists, medical physicists and allied scientists.
According to the American Cancer Society, an estimated 231,840 new cases of invasive breast cancer, along with 60,290 new cases of non-invasive (in situ) breast cancer, will be diagnosed in U.S. women in 2015. An estimated 40,290 women in the U.S. are expected to die in 2015 from breast cancer. Only lung cancer accounts for more cancer deaths in women.
About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno's Imagio OA breast imaging system fuses opto-acoustic technology with ultrasound to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around suspicious breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of the two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno believes that the Imagio OA breast imaging system 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 OA technology may also address other disease applications in organs other than the breast, as well as assessing other breast problems, such as early response to chemotherapy or hormonal treatments of breast cancer. To learn more about Seno Medical's opto-acoustic imaging technology and applications, visit www.SenoMedical.com.
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