Presentation (CTI)

OBJECTIVES: Contrast-enhanced mammography (CEM) is an imaging modality that combines mammography with intravenous iodinated contrast administration to visualize contrast-enhancing breast lesions. This study evaluated the safety and effectiveness of CEM for the diagnosis and follow-up of breast disease as part of the Korean New Health Technology Assessment (nHTA).
METHODS: A rapid evidence review was conducted in accordance with the review criteria for miscellaneous tests under the Korean nHTA framework. Evidence included international clinical guidelines, a National Institute for Health and Care Excellence (NICE) report, and published systematic reviews. Safety and effectiveness were assessed by a multidisciplinary expert subcommittee consisting of radiologists, breast surgeons, a radiation oncologist, a pathologist, and an evidence-based medicine specialist.
RESULTS: Evidence was identified from 11 international guidelines, one NICE report, and 10 systematic reviews. Major professional societies consistently recommended CEM as an adjunct imaging modality or an alternative to breast magnetic resonance imaging (MRI) for breast disease diagnosis and follow-up. CEM demonstrated diagnostic performance comparable to MRI for breast cancer detection, staging, and treatment response assessment. The NICE report, based on studies involving 1,809 women with confirmed or suspected breast cancer, suggested that CEM may provide a practical alternative for patients with dense breasts or contraindications to MRI. Systematic reviews reported high sensitivity for breast cancer detection and diagnostic accuracy comparable to MRI. Reported contrast-related adverse events were infrequent, with mild allergic reactions occurring in 0.13% of patients and no severe adverse events reported.
CONCLUSIONS: Available evidence indicates that CEM is a safe and effective imaging technology for the diagnosis and follow-up of breast disease. CEM provides diagnostic performance comparable to MRI while offering an alternative option for patients who cannot undergo MRI. Based on these findings, the Korean nHTA Committee concluded that CEM is a safe and effective health technology for clinical use.