News | Ultrasound Women's Health | September 29, 2015

Seno Medical Instruments Completes PIONEER Study of Imagio Breast Imaging System

Optoacoustics technology shown to reduce false positives requiring follow-up breast biopsy procedures

Seno Medical Instruments, Imagio breast imaging system, PIONEER Study, optoacoustics

Image courtesy of Seno Medical Instruments

September 29, 2015 — Seno Medical Instruments Inc. (Seno) announced it has completed the final phase of the company's U.S.-based PIONEER pivotal study of the Imagio breast imaging system. The system utilizes optoacoustic technology as a new tool to improve the process of diagnosing breast cancer.

The PIONEER Study was designed to demonstrate that the Imagio breast imaging system can provide physicians with vital information they need to determine whether a suspicious breast mass is cancerous or not, helping women avoid negative biopsy procedures. Results from this study will serve as the basis for the company's Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA).

The system fuses optoacoustics, a technology based on "light-in and sound-out," with diagnostic ultrasound. The optoacoustic images provide a unique blood map in and around suspicious breast masses. Cancerous tumors grow relatively quickly and require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses. Imagio provides real-time images of these networks and a map of relative oxygen-rich or oxygen-deprived blood. Unlike other functional fusion technologies, Imagio uses no X-rays (ionizing radiation) or injectable contrast agents or radioisotopes to obtain its information, thereby reducing the patient's exposure to any potentially harmful aspects of imaging.

"In light of the fact that a large majority of biopsies reveal benign pathology, we believe that Imagio could potentially help reduce the number of procedures generated by false positives by providing physicians with more information and thus be more confident in their imaging assessments," said Erin Neuschler, M.D., Northwestern Medicine radiologist, assistant professor of radiology at the Northwestern University Feinberg School of Medicine and the co-principal investigator of the PIONEER Study. "Data from prior Seno studies demonstrated Imagio's potential to achieve clinically meaningful diagnostic sensitivity and specificity for breast cancer beyond those delivered by traditional, diagnostic ultrasound. It is our hope and belief that the results of this study will confirm these earlier findings."

"We started doing basic research with optoacoustics back in 2005 and it is noteworthy to see this rigorously conducted trial of this technology completed. We await the final analysis now that all of the patients have enrolled in the trial," said Stephen Grobmyer, M.D., director of breast services and principal investigator of the trial at Cleveland Clinic. "Based on our clinical experience to date, it appears this breast cancer imaging technology could enhance both the physician and the patient experience by reducing the number of false positive cases, which we currently face assessing patients with abnormal breast imaging."

The study was conducted in 16 leading institutions throughout the United States, with more than 2,100 subjects enrolled. The study was designed to measure the sensitivity and specificity of Imagio compared to grayscale ultrasound imaging in breast lesions using the probability of malignancy (POM). Subjects underwent a traditional ultrasound and an Imagio scan. The radiologist used clinical mammography and traditional ultrasound findings to determine if the subject should advance to the biopsy phase. The Imagio results were later interpreted by an independent reader panel. Subjects who were put into follow-up were re-evaluated 12 months after their initial examination to confirm the results as a true negative.

After the interim analysis of the PIONEER Study, Seno initiated a separate European post-marketing and clinical follow-up study, the MAESTRO Study. The company currently has five sites participating in this study in the Netherlands.

Results from the MAESTRO Study will be presented at the upcoming 2015 European Society of Breast Imaging Annual Scientific Meeting (EUSOBI), Oct. 2–3 in London. The results of the PIONEER Pilot Study will be presented at the Radiological Society of North America (RSNA) annual meeting, Nov. 29 – Dec. 4 in Chicago.

Seno Medical Instruments, Inc. has provided support for the research done at Cleveland Clinic and Northwestern University and paid for travel related to the participation in the trial for Grobmyer and Neuschler, respectively.

For more information: www.senomedical.com

Related Content

Category A

Category A

Feature | Breast Density | April 03, 2020 | By Dayna Williams M.D., Shivani Chaudhry, M.D., and Laurie R. Margolies, M.D.
Breast cancer is the most common cance
#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2
News | Mammography | March 25, 2020
March 25, 2020 — The...
The 2020 Society of Breast Imaging/American College of Radiology (SBI/ACR) annual symposium has been cancelled, and the event rescheduled for April 8-11, 2020, in Savannah, Ga. #COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SBI20
News | Society of Breast Imaging (SBI) | March 16, 2020
March 16, 2020 — The 2020 Society of Breast Imaging/American College of Radiology (...
DBT, sometimes called 3-D mammography, emerged in the last decade as a powerful tool for breast cancer screening

Images in a 57-year-old woman noted to have "good prognosis" invasive cancer detected at digital breast tomosynthesis (DBT) screening. (a) Craniocaudal view of the left breast obtained with the two-dimensional digital mammography (DM) portion of the DM/DBT screening study demonstrates a subtle area of distortion in the medial left breast. (b) Single-slice image from the left craniocaudal DBT portion of the screening study shows an area of bridging distortion (circle). (c) Electronically enlarged image of the area of concern seen on the left craniocaudal view in a single DBT slice as shown in b. (d) Targeted US scan demonstrates two small adjacent irregular solid masses. US-guided core biopsy yielded an invasive carcinoma of the tubular subtype that was estrogen receptor positive, progesterone receptor positive, and human epidermal growth factor receptor 2 negative. The results of the sentinel node biopsy were negative. Image courtesy of the Radiological Society of North America

News | Breast Imaging | March 11, 2020
March 11, 2020 — A new study published in the journal ...
SoftVue image stacks of sound speed, as shown for cases ranging across the four Breast Imaging Reporting and Data System (BI-RADS) breast density categories

Example: SoftVue image stacks of sound speed, as shown for cases ranging across the four Breast Imaging Reporting and Data System (BI-RADS) breast density categories ((a), fatty; (b), scattered; (c), heterogeneously dense; (d), extremely dense). Note the quantitative scale indicating that absolute measurements are obtained. Image courtesy of MDPI

News | Breast Imaging | March 10, 2020
March 10, 2020 — ...
The study concludes that a combination of Artificial Intelligence algorithms and the interpretations of radiologists could, in the U.S. alone, result in a half million women not having to undergo unnecessary diagnostic tests every year

Researchers who participated in the DM (digital mammography) DREAM Challenge.

News | Mammography | March 07, 2020
March 7, 2020 — The stu...
Christopher Comstock, M.D., ECOG-ACRIN Cancer Research Group study published in JAMA builds evidence for use of abbreviated MRI in women with dense breasts

Christopher Comstock, M.D., (Memorial Sloan Kettering Cancer Center) is the lead author of a paper in JAMA that reports that abbreviated breast MRI detected significantly more (almost 2 and a half times as many) breast cancers than digital breast tomosynthesis (3-D mammography) in average-risk women with dense breasts. Photo courtesy of Memorial Sloan Kettering Cancer Center

News | Breast Imaging | February 26, 2020
February 26, 2020 — According to a study
Women 75-plus May Not Benefit from Breast Cancer Screening
News | Mammography | February 25, 2020
February 25, 2020 — According to newly published research in an article titled...
Recognized as the “Pulitzer Prize of the business press,” the Jesse H. Neal Award finalists are selected for exhibiting journalistic enterprise, service to the industry and editorial craftsmanship
News | Radiology Business | February 19, 2020
February 19, 2020 — Connectiv, a division of The Software and Information Industry Association (SIIA), has announced