Seno Medical Instruments announced that it has completed active enrollment of subjects in its US-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).
"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, MD, 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 radio-isotopes, 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 investigator Erin Neuschler, MD, 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 U.S. 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.