Seno Medical Instruments, the company pioneering the development of opto-acoustic technology as a new tool to improve the process of diagnosing breast cancer, announced it has completed the final phase of the company's U.S.-based PIONEER Pivotal Study of the Imagio breast imaging system.
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).
Imagio 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.
The technology 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 including magnetic resonance imaging (MRI) or positron emission tomography (PET).
"We started doing basic research with opto-acoustics 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, MD, Director of Breast Services and principal investigator of the trial at Cleveland Clinic.
The PIONEER 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 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.
"We are pleased to have completed the final phase for the PIONEER Study. I would like to thank our sites and readers for their commitment to this important milestone," said Tom Miller, CEO of Seno Medical Instruments.
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), the second largest conference dedicated to breast cancer imaging.
The EUSOBI meeting will take place on October 2-3 in London. The results of the PIONEER Pilot Study will be presented at the Radiological Society of North America Annual Meeting (RSNA), the premiere conference in the world for radiology, from November 29 – December 4 in Chicago, Illinois.
Seno Medical Instruments 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 Dr. Grobmyer and Dr. Neuschler respectively.