Development of a novel framework to evaluate the localization accuracy of tomosynthesis-guided breast biopsy units

To develop a scheme to quantitatively assess localization accuracy of tomosynthesis-guided vacuum-assisted breast biopsy apparatus.

A phantom containing a metallic pellet on a flexible plastic shaft was constructed and was tested in cranio-caudal (CC) and lateral (LAT) arm biopsy geometries following the standard clinical breast biopsy workflow. Three points were manually digitized on tomosynthesis images including: the center of the target, and the tip of the needle in pre- and postfire positions. The needle trajectory was determined and four error metrics were defined: (1) stroke length error (difference between the nominal and measured stroke lengths); (2) Euclidian distance between the target and center of trough (i.e., aperture); (3) longitudinal distance between target and center of trough; and (4) lateral distance between target and needle. The proposed methodology was also evaluated on a breast gel phantom and the complete biopsy procedure, including vacuum-assisted biopsy was performed.

Three biopsy geometries were investigated: (i) LAT arm on a prone table unit (Hologic, Affirm Prone), (ii) CC- and (iii) LAT arm in an upright unit (Hologic Affirm Upright). Both biopsy units passed the vendor-provided daily localization accuracy test, with <1 mm nominal error in each dimension. The aforementioned error metrics (1) to (4) were (0.6, 1.8, 0.4, 1.7) mm, (0.4, 4.2, 4.1, 1.1) mm, and (0.3, 2.4, 0.7, 2.3) mm, respectively, for geometry-I, -II, and -III. The gel phantom was tested on the upright unit with lateral arm and the error metrics (1) to (4) were 0.4, 2.5, 0.8, and 2.4 mm respectively.

A framework was developed to evaluate the tomosynthesis-guided breast biopsy localization error, allowing quantitative comparisons between different systems and biopsy configurations. The proposed framework can also be extended to the stereotactic breast biopsy units. We suggest that a quantitative tolerance level for localization accuracy of breast biopsy units be established.