Pilot Study Results of Novel Breast Imaging System Released

The pilot study compared the device to traditional ultrasound, and showed that the device had the potential to improve the ability of clinicians to classify benign breast masses accurately.

Seno Medical Instruments (San Antonio, TX, USA) developed the Imagio breast imaging device, and is a pioneer in Optoacoustic (OA) tool for diagnosing breast cancer. The device can identify the presence of abnormal blood vessels and the relative reduced levels of oxygen in the blood of cancerous tissue compared to benign masses, or healthy normal tissue. OA imaging is noninvasive, does not use contrast agents, ionizing radiation, or radio-isotopes, as do other modalities such as Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET).

The pilot study that included 100 subjects was part of the US-based multicenter PIONEER pivotal study with more than 2,000 subjects. In the pilot study seven independent breast radiologist readers and an expert radiologist trainer were asked to blindly assess 102 masses using only OA images made by the Imagio device. Immediately before the OA exam the researchers also made conventional grey-scale ultrasound exams, as internal ultrasound controls, and the independent readers also assigned a Breast Imaging-Reporting and Data System (BI-RADS) score to these images. In addition, a total of 39 benign and 36 malignant masses were biopsied.

The results of the pilot study showed that the device can be used to help clinicians identify women who do not have breast cancer, and spare them the agony of undergoing invasive biopsy procedures and/or follow-up exams over a two year period.

Erin Neuschler, MD, Northwestern Medicine radiologist, co-principal investigator of the PIONEER study, said, "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. 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."

Related Links:
Seno Medical Instruments