US-based Seno Medical Instruments has announced new statistical analysis of outcomes from a feasibility study of its investigational Imagio breast imaging device.
The analysis of data from the feasibility study, presented at the San Antonio Breast Cancer Symposium (SABCS) 2013 (Abstract P4-01-14) on 13 December 2013, suggests that information from Imagio may have the potential to achieve clinically-meaningful sensitivity and specificity for breast cancer beyond those achievable with traditional, standalone diagnostic ultrasound.
If confirmed in a larger pivotal study – currently underway in the US – Imagio may be a useful tool to help physicians rule out the need for a biopsy in patients with benign breast masses.
This new statistical analysis of various features of benign and malignant lesions captured in the Imagio opto-acoustic images during the feasibility study also suggests that Imagio may have the potential to provide additional information that could help clinicians grade the aggressiveness of cancerous breast tumors during the imaging phase of a woman’s diagnosis, if verified in the ongoing pivotal study.
Imagio combines an imaging technology based on light-in and sound-out called ‘opto-acoustics’ with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.
For this study, proposed classification guidelines were developed to help identify features that differentiate images of benign and cancerous lesions, as well as the aggressiveness of the tumor.
To develop the proposed classification guidelines, images of each tumor were assessed using three internal and two external features, which were scored on an ordinal scale from zero to five. The results were then summed to get a total internal score, total external score, and a total score. These results were then analyzed with five statistical classification methods.
Seno Medical Instruments medical director Dr Thomas Stavros noted the company is encouraged to see a high correlation between pathology results and classified features of masses captured in Imagio opto-acoustic images as part of this feasibility study.
"Our ongoing Pivotal Study will hopefully provide evidence to confirm our hypothesis and this early data," Dr Stavros added.