Abstract Objective This systematic review and meta-analysis investigate the added value of contrast-enhanced breast MRI (CE-MRI) to rule out malignancy in patients with high-risk (B3) lesions diagnosed at image-guided biopsy. Materials and methods A systematic review and meta-analysis were performed using predefined criteria. Eligible English-language articles published until August 2024 focused on CE-MRI in high-risk lesions. Two reviewers extracted data on true positives (TP), false positives (FP), true negatives (TN), and false negatives (FN). Sensitivity, specificity, negative and positive likelihood ratios were calculated using a bivariate random-effects model. Fagan nomograms identified the maximum pretest probability at which post-test probabilities of a negative MRI matched the 2% malignancy threshold used for downgrading BI-RADS 4 to 3. I² statistics and meta-regression explored heterogeneity. p -values < 0.05 were considered significant. Results Seven studies comprising 479 patients with 493 high-risk lesions undergoing CE-MRI were included. The average breast cancer prevalence was 17% (88/493). Pooled sensitivity was 91.3% (95% CI: 82.8–95.8%) and pooled specificity was 68.8% (95% CI: 50.3–82.8%). Only 6/493 malignancies were missed by CE-MRI; all were small low-grade ductal carcinoma in situ (DCIS). Fagan nomograms indicated that CE-MRI could rule out malignancy in lesions with pretest probabilities up to 13.1%. Conclusions CE-MRI in assessing high-risk lesions may help identify patients who can safely avoid surgery, potentially reducing morbidity, anxiety, and healthcare resource use. Malignancy can be reliably ruled out in lesions with pretest probabilities ≤ 13.1%, although prospective studies are suggested for confirmation. Key Points Question Can contrast-enhanced breast MRI help to rule out malignancy in patients with high-risk lesions at imaging-guided biopsy, thereby supporting more tailored decisions and potentially reducing unnecessary surgical excisions? Findings Contrast-enhanced breast MRI may reduce unnecessary surgical or vacuum excisions in high-risk (B3) lesions. Missed cancers were limited to small low-grade DCIS. Clinical relevance Contrast-enhanced breast MRI may support the identification of patients with high-risk lesions who could potentially avoid surgery. This non-invasive approach has the potential to reduce overtreatment, healthcare costs, and patient anxiety, while maintaining a high negative predictive value. Graphical Abstract
Vatteroni et al. (2026) studied this question.