Breast cancer is the most common cancer for females with 2M new cases worldwide in 2018.
Breast biopsies are a critical step in the diagnosis of suspect breast lesions, it is a procedure where part or all of a suspicious breast tissue growth is sampled and examined for the presence of cancer.
If the histological analysis of the tissue collected in the biopsy does not match the mammography, the patient will have to undergo a new biopsy. If the tissue removed for histological analysis does not correspond to the most advanced stage of the disease, the diagnosis will be incorrect and the patient might not receive adequate treatment.
NLBB used to be the gold standard procedure for the diagnosis of non-palpable breast lesions. However, it is a surgical procedure with high costs and for most of the patients, a traumatic experience. In the past few decades, less traumatic and cost-saving non-operative image-guided techniques, such as FNA and LCNB, have been advocated as an alternative.
However, even with the most advanced available methods, the staging of the cancer disease based on the biopsy sample remains a major challenge. The cancer is often “under-staged”, meaning that the sample collected for pathological examination does not reflect the most advanced stage of the disease and therefore the follow-up patient treatment is not optimized. In addition, up to 6% of the biopsies lead to false negative results, which means that some of the cancers are missed and the correct diagnosis is only done later, once cancer has progressed further. Furthermore, up to 18% of the patients have to undergo repeat biopsies due to inconsistent findings between histopathological and imaging analyses. In practice, about 25% of these repeat biopsies eventually lead to a carcinoma diagnosis, simply because the initial biopsy was not taken from the most advanced stage of the disease.
Altogether, every one million patients undergoing core needle biopsy will generate, on average:
•200,000 repeat procedures during which approximately 50,000 patients will be upgraded to a malignancy.
•Up to 40,000 patients incorrectly diagnosed as healthy.
•5,000 hematomas and 10,000 infections related to open biopsies perform to rule out malignancies.
SmartGuide is a novel type of diagnostic modality based on dielectric spectroscopy providing real-time information regarding the tissue properties during the biopsy procedure, it does not replace the need for histological analysis, but it makes sure that the excised tissue represents the most advanced stage of the disease so the subsequent histological analysis leads to an accurate diagnosis.
The main objective of the project is to improve the accuracy of the diagnosis, reduce the under staging risk by 95%, reduce the false negative rate by 80%, reduce the number of repeat biopsies by 80% and the number of excisional open breast biopsies by 50%.
The project results will lead to improved diagnosis, reduced clinical risks associated with unnecessary biopsies, and ultimately reduce costs for health providers, while improving the standard of care and quality of life for the patients.
