Photon-Counting Spiral Breast CT-guided Vacuum-Assisted Biopsy: A Phantom-based Pre-clinical Feasibility Study

Abstract Objectives Photon-counting spiral breast computed tomography (SBCT) has been introduced as a promising fully three-dimensional imaging system capable of providing enhanced lesion detection and characterization. The aim of this study was to evaluate technical feasibility and usability for photon-counting SBCT-guided interventions in a pre-clinical setting using a newly developed biopsy suite and anthropomorphic compressible breast phantoms. Materials and Methods The clinically certified SBCT device has been updated by the vendor to additionally allow for image-guided minimally invasive interventional procedures of the breast. The biopsy unit allows for grid-based localization method in vacuum-assisted biopsy (VAB). New scan protocols and reconstruction profiles were provided to allow for fast and accurate navigation to user-defined target lesions of all types. Six deformable, anthropomorphic, and biopsy-compatible breast phantoms of different sizes were used in this study. A total of 30 lesions (low-contrast mass lesions and clusters of calcifications of 125 µm in size) were biopsied by four clinical users employing certified third-party VAB system and equipment. Technical feasibility and usability were assessed based on the lesion targeting success rate, intervention time, and mean glandular dose. Results The rate of success in needle navigation was 100%, regardless of lesion type, size, and location. The total intervention time and mean glandular dose for the VAB procedure consisting of one planning scan followed by two control scans were 9.68 ± 1.05 min (range: 7.82–12.35 min) and 11.34 ± 1.50 mGy (range: 7.81–13.75 mGy), respectively. The investigators reported no device-related events, device deficiencies, or difficulties in performing the biopsy procedure. Conclusions This phantom-based pre-clinical study showed that photon-counting SBCT with biopsy functionality enables accurate and fast true three-dimensional guidance of minimally invasive interventional procedures in the breast at very low radiation dose. It could be a valuable tool for taking samples of lesions that are difficult or impossible to detect in conventional breast imaging.