Development of an integrated 3D ABUS system with needle biopsy capabilities and combined 3D ABUS-MRI-guided needle biopsy

Breast cancer is the most common cancer among women worldwide, with two million diagnoses and 685,000 annual deaths. Breast needle biopsy is the primary method to definitively confirm a breast cancer diagnosis, which is guided typically by ultrasound. However, operator-dependence makes ultrasound-guided needle biopsies difficult to perform. Moreover, for women with dense breast tissue or suspicious lesions that are not visualized well under ultrasound, MRI-guided breast needle biopsies are recommended instead. However, the MRI-based biopsy procedure is inaccessible in some centers, costly, and highly time-consuming. To address these challenges, we developed a 3D automated breast ultrasound (3D ABUS) system, compatible with any commercial ultrasound probe, to facilitate breast needle biopsy procedures, with an integrated needle biopsy mechanism. Our integrated system consists of an MRI-compatible 3D-printed wearable base and compression subassembly, and a motorized linear ultrasound scanner. We evaluated the 3D ABUS-MRI image registration capabilities of our system using a custom breast phantom. The integrated system displayed high accuracy in lesion localization, with mean target registration error (TRE) and fiducial localization error (FLE) of 0.45 mm and 0.31 mm, respectively. These results confirm the system’s effectiveness in co-localizing lesions in MRI and 3D ABUS modalities. This advancement in integrating 3D ABUS with breast needle biopsy offers a more cost-effective and accessible solution, potentially improving breast biopsy procedure workflow and patient experience, particularly in women with dense breasts.