CEUS-Guided Core Needle Biopsy Reduces Underestimation in Breast Lesions: A Prospective Randomized Study

RATIONALE AND OBJECTIVES: To evaluate whether contrast-enhanced ultrasound (CEUS) guidance improves the diagnostic accuracy of core needle biopsy (CNB) for breast lesions and reduces the underestimation rate, while identifying the patient population most likely to benefit from this approach.

This single-center prospective randomized controlled trial included 340 patients scheduled for ultrasound-guided breast lesion biopsy at our institution between August 1, 2023, and December 31, 2024. Participants were randomly assigned to receive either conventional ultrasound-guided CNB or CEUS-guided CNB. Using surgical pathology as the reference standard, diagnostic accuracy, underestimation rate (defined as the proportion of cases where high-risk lesions on biopsy were upgraded to malignant lesions on surgical pathology), and agreement with postoperative immunohistochemistry were compared between the two groups. The median age was 53.0 years (interquartile range [IQR], 45.0-66.3 years) in the conventional group and 56.0 years (IQR, 44.8-66.0 years) in the CEUS group, with no significant differences in baseline demographic and clinical characteristics between groups.

The CEUS-guided CNB group demonstrated significantly higher diagnostic accuracy than the conventional group (93.5% vs. 82.4%, P=0.02), along with lower overall underestimation rate (40.7% vs. 73.2%, P=0.007) and false-negative rate (3.1% vs. 13.9%, P=0.002). Multivariate analysis identified CEUS guidance as an independent predictor of biopsy accuracy (OR 3.094, P=0.004). Subgroup analysis showed superior accuracy of CEUS-guided CNB in premenopausal patients, lesions with microcalcifications, and those with heterogeneous internal echoes (all P<0.05). Among patients with invasive cancer, the concordance rate of molecular subtypes between biopsy and surgical pathology was significantly higher in the CEUS group than in the conventional group (85.7% vs. 74.8%, P=0.043), while concordance for ER, PR, HER-2, and Ki-67 did not differ significantly between groups.

CEUS can improve the accuracy of core needle biopsy for breast lesions, reducing false-negative rates and underestimation rates. It can enhance the consistency of molecular subtypes between puncture biopsy and surgical pathology in breast cancer patients, providing a stronger basis for clinical decision-making in personalized treatment plans. CEUS-guided CNB may be preferentially considered for premenopausal patients and for lesions with microcalcifications or heterogeneous internal echoes visible on conventional ultrasound.