Abstract
OBJECTIVE: To assess the ability of the pressure gradient between breast lesions and adjacent normal tissue estimated by 3D subharmonic-aided pressure estimation (SHAPE) to characterize indeterminate breast lesions. METHODS: This prospective study enrolled patients scheduled for ultrasound-guided needle biopsies of a breast lesion. Before the biopsy, 3D SHAPE data were collected from the breast lesion during the infusion of an ultrasound contrast agent (Definity) as well as after clearance of the agent. Direct, invasive pressure measurements in the lesion and adjacent normal tissue were then obtained using an intracompartmental pressure monitoring system (C2DX) before tissue sampling as part of the biopsy procedure. The mean SHAPE gradient and invasive measurement gradient between the lesion and adjacent normal tissue were compared to the biopsy results. The SHAPE gradients were also compared to the invasive pressure gradients. RESULTS: There were 8 malignant and 13 benign lesions studied. The SHAPE gradients and invasive pressure gradients were significantly different between the benign and malignant lesions (2.86 ± 3.24 vs. -0.03 ± 1.72 a.u.; p = 0.03 and 9.9 ± 8.5 vs. 20.9 ± 8.0 mmHg; p = 0.008, respectively). The area under the curves, specificities, and sensitivities for detecting malignancy by SHAPE gradients and invasive pressure gradients were 0.79 and 0.88, 77% and 92%, and 88% and 50%, respectively. A weak negative correlation was found between the SHAPE and invasive pressure gradients (r = -0.2). CONCLUSION: The pressure gradient between a breast lesion and adjacent normal tissue estimated by 3D SHAPE shows potential for characterizing indeterminate breast lesions.