Production and clinical evaluation of breast lesion skin markers for automated three-dimensional ultrasonography of the breast: a pilot study

Objectives: Automated ultrasound of the breast has the advantage to have the whole breast scanned by technicians. Consequently, feedback to the radiologist about concurrent focal abnormalities (e.g., palpable lesions) is lost. To enable marking of patient- or physician-reported focal abnormalities, we aimed to develop skin markers that can be used without disturbing the interpretability of the image. Methods: Disk-shaped markers were casted out of silicone. In this IRB-approved prospective study, 16 patients were included with a mean age of 57 (39–85). In all patients, the same volume was imaged twice using an automated breast ultrasound system, once with and once without a marker in place. Nine radiologists from two medical centers filled scoring forms regarding image quality, image interpretation, and confidence in providing a diagnosis based on the images. Results: Marker adhesion was sufficient for automated scanning. Observer scores showed a significant shift in scores from excellent to good regarding diagnostic yield/image quality (χ ², 15.99, p < 0.01), and image noise (χ ², 21.20, p < 0.01) due to marker presence. In 93% of cases, the median score of observers “agree” with the statement that marker-induced noise did not influence image interpretability. Marker presence did not interfere with confidence in diagnosis (χ ², 6.00, p = 0.20). Conclusion: Inexpensive, easy producible skin markers can be used for accurate lesion marking in automated ultrasound examinations of the breast while image interpretability is preserved. Any marker-induced noise and decreased image quality did not affect confidence in providing a diagnosis. Key Points: • The use of a skin marker enables the reporting radiologist to identify a location which a patient is concerned about. • The developed skin marker can be used for accurate breast lesion marking in ultrasound examinations.