News | October 07, 2014

Seno Medical Completes Enrollment in U.S. Pivotal Study of Imagio Breast Imaging System

Seno Medical Enrollment U.S. Pivotal Study Imagio Breast Imaging System

October 7, 2014 — Seno Medical Instruments Inc. announced it has completed active enrollment of subjects in its U.S.-based PIONEER Pivotal Study of Imagio. The study was designed to determine if this technology will provide information to the physician to determine if a woman may avoid negative biopsies. This information will serve as the basis for the company's Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA).

Seno's Imagio fuses opto-acoustics, a technology based on "light-in and sound-out," with diagnostic ultrasound. The opto-acoustic 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 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 to obtain its information, thereby reducing the patient's exposure to any potentially harmful aspects of imaging.

"There is a significant unmet medical need for more accurate diagnostic imaging technologies to help physicians confirm and rule out breast cancer before the patient has to undergo an invasive procedure. More information at the imaging stage could help us make more informed decisions regarding whether we should send the patient for a surgical or needle biopsy," said Reni Butler, M.D., assistant professor of diagnostic radiology at the Yale School of Medicine in New Haven, Conn., and the co-principal investigator for the study.

Imagio was designed to identify two functional hallmarks of a potential malignancy: the presence of abnormal blood vessels (angiogenesis) and the relative reduction in oxygen content of hemoglobin. The technology is non-invasive and does not require contrast agents or radioisotopes, which are required for other modalities such as magnetic resonance imaging (MRI) or positron emission tomography (PET), nor does it use ionizing radiation (X-ray).

"Earlier data from a feasibility study of Imagio led to encouraging results and we look forward to seeing the outcomes from this pivotal study. If the results are consistent with the earlier, smaller studies, we believe this could be an important new technology to help improve the diagnosis of breast cancer and allow many women with benign lesions to have short-interval Imagio follow-up and avoid a biopsy," said co-principal investigatorErin Neuschler, M.D., Northwestern Medicine radiologist and assistant professor of radiology at Northwestern University Feinberg School of Medicine in Chicago.

The Imagio 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 Imagio grayscale ultrasound imaging in breast lesions using the probability of malignancy (POM). Subjects who enrolled in the study underwent a traditional ultrasound and an Imagio scan. Physicians only used 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 had a negative diagnostic ultrasound will be re-evaluated 12 months after their initial examination to confirm the negative results as a true negative.

"Completing active enrollment is a significant milestone in Seno's efforts to commercialize Imagio. We developed Imagio with the goal of reducing the number of imaging tests and invasive procedures women currently have to undergo to learn if a suspicious breast mass is cancerous or not. We would like to thank our investigators and their dedicated teams for participating in this important study. We hope Imagio will have a significant impact on the diagnosis of breast cancer in the future," said Janet Campbell, CEO of Seno Medical Instruments.

For more information: www.SenoMedical.com

Related Content

MRI Reveals Striking Brain Differences in People with Genetic Autism

Example images for a control participant , a deletion carrier, and a duplication carrier. In the sagittal image of the deletion carrier, the thick corpus callosum, dens and craniocervical abnormality, and cerebellar ectopia are shown. For the duplication carrier, the sagittal image shows the thin corpus callosum and the axial image shows the increased ventricle size and decreased white matter volume. Image courtesy of the Radiological Society of North America (RSNA).

News | Neuro Imaging | August 09, 2017
August 9, 2017 — In the first major study of its kind, researchers using magnetic...
Clinical Data Supports Use of Xoft System for Endometrial Cancer
News | Brachytherapy Systems | August 03, 2017
Researchers presented clinical data supporting use of the Xoft Axxent Electronic Brachytherapy (eBx) System for the...
brain with chronic traumatic injury
News | Magnetic Resonance Imaging (MRI) | August 02, 2017
Fighters are exposed to repeated mild traumatic brain injury (mTBI), which has been associated with neurodegenerative...
The ASPIRE Cristalle FFDM system with DBT combines Fujifilm’s state-of-the-art hexagonal close pattern (HCP) detector design, advanced image processing and image acquisition workflow
News | Women's Health | August 01, 2017
Fujifilm Medical Systems U.S.A., Inc. announced that The Mammography Center of Monterey, an ACR-accredited breast...
NIH-funded scientists have discovered that Parkinson’s disease increases the amount of “free” water in a particular brain area

NIH-funded scientists have discovered that Parkinson’s disease increases the amount of “free” water in a particular brain area. Image courtesy of David Vaillancourt, Ph.D., University of Florida.

News | Neuro Imaging | July 31, 2017
Scientists at the University of Florida have discovered a new method of observing the brain changes caused by Parkinson...
more healthcare providers and patients are choosing options such as Gamma Knife stereotactic radiosurgery
News | Radiation Therapy | July 31, 2017
Each year, up to 650,000 people who were previously diagnosed with various forms of cancer will develop brain...
Sponsored Content | Videos | Breast Imaging | July 28, 2017
Nancy Cappello, Ph.D., executive director and founder of Are You Dense Inc. and Are You Dense Advocacy, explains how
"Residual Echo" of Ancient Humans May Hold Clues to Mental Disorders

MRI data shows (left) areas of the skull preferentially affected by the amount of Neanderthal-derived DNA and (right) areas of the brain’s visual system in which Neanderthal gene variants influenced cortex folding (red) and gray matter volume (yellow). Image courtesy of Michael Gregory, M.D., NIMH Section on Integrative Neuroimaging

News | Neuro Imaging | July 26, 2017
Researchers from the National Institute of Mental Health (NIMH) have produced the first direct evidence that parts of...
New York Hospital Finds Significant Cost Savings With Toshiba’s Aquilion One CT
News | Computed Tomography (CT) | July 25, 2017
In five years, Kaleida Health’s Stroke Care Center (SCC) at the Gates Vascular Institute in Buffalo, N.Y., has realized...
Overlay Init