Michael Golatta1, André Pfob2, Christopher Büsch3, Thomas Bruckner3, Zaher Alwafai4, Corinne Balleyguier5, Dirk-André Clevert6, Volker Duda7, Manuela Goncalo8, Ines Gruber9, Markus Hahn9, Panagiotis Kapetas10, Ralf Ohlinger4, Matthieu Rutten11, Riku Togawa12, Mitsuhiro Tozaki13, Sebastian Wojcinski14, Geraldine Rauch15, Joerg Heil12, Richard G Barr16. 1. University Breast Unit, Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany. Electronic address: Michael.golatta@med.uni-heidelberg.de. 2. University Breast Unit, Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany. Electronic address: https://twitter.com/andrepfob. 3. Institute of Medical Biometry (IMBI), Heidelberg University, Heidelberg, Germany. 4. Department of Gynecology and Obstetrics, University of Greifswald, Greifswald, Germany. 5. Department of Radiology, Institut Gustave Roussy, Villejuif Cedex, France. 6. Department of Radiology, University Hospital Munich-Grosshadern, Munich, Germany. 7. Department of Gynecology and Obstetrics, University of Marburg, Marburg, Germany. 8. Department of Radiology, University Hospital of Coimbra, Coimbra, Portugal. 9. Department of Gynecology and Obstetrics, University of Tuebingen, Tuebingen, Germany. 10. Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria. 11. Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands; Diagnostic Image Analysis Group, Radboud University Medical Center, Nijmegen, the Netherlands. 12. University Breast Unit, Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany. 13. Department of Radiology, Sagara Hospital, Kagoshima, Japan. 14. Department of Gynecology and Obstetrics, Breast Cancer Center, Klinikum Bielefeld Mitte GmbH, Bielefeld, Germany. 15. Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany. 16. Department of Radiology, Northeast Ohio Medical University, Ravenna, USA.
Abstract
BACKGROUND: Shear wave elastography (SWE) and strain elastography (SE) have shown promising potential in breast cancer diagnostics by evaluating the stiffness of a lesion. Combining these two techniques could further improve the diagnostic performance. We aimed to exploratorily define the cut-offs at which adding combined SWE and SE to B-mode breast ultrasound could help reclassify Breast Imaging Reporting and Data System (BI-RADS) 3-4 lesions to reduce the number of unnecessary breast biopsies. METHODS: We report the secondary results of a prospective, multicentre, international trial (NCT02638935). The trial enrolled 1288 women with BI-RADS 3 to 4c breast masses on conventional B-mode breast ultrasound. All patients underwent SWE and SE (index test) and histopathologic evaluation (reference standard). Reduction of unnecessary biopsies (biopsies in benign lesions) and missed malignancies after recategorising with SWE and SE were the outcome measures. RESULTS: On performing histopathologic evaluation, 368 of 1288 breast masses were malignant. Following the routine B-mode breast ultrasound assessment, 53.80% (495 of 920 patients) underwent an unnecessary biopsy. After recategorising BI-RADS 4a lesions (SWE cut-off ≥3.70 m/s, SE cut-off ≥1.0), 34.78% (320 of 920 patients) underwent an unnecessary biopsy corresponding to a 35.35% (320 versus 495) reduction of unnecessary biopsies. Malignancies in the new BI-RADS 3 cohort were missed in 1.96% (12 of 612 patients). CONCLUSION: Adding combined SWE and SE to routine B-mode breast ultrasound to recategorise BI-RADS 4a patients could help reduce the number of unnecessary biopsies in breast diagnostics by about 35% while keeping the rate of undetected malignancies below the 2% ACR BI-RADS 3 definition.
BACKGROUND: Shear wave elastography (SWE) and strain elastography (SE) have shown promising potential in breast cancer diagnostics by evaluating the stiffness of a lesion. Combining these two techniques could further improve the diagnostic performance. We aimed to exploratorily define the cut-offs at which adding combined SWE and SE to B-mode breast ultrasound could help reclassify Breast Imaging Reporting and Data System (BI-RADS) 3-4 lesions to reduce the number of unnecessary breast biopsies. METHODS: We report the secondary results of a prospective, multicentre, international trial (NCT02638935). The trial enrolled 1288 women with BI-RADS 3 to 4c breast masses on conventional B-mode breast ultrasound. All patients underwent SWE and SE (index test) and histopathologic evaluation (reference standard). Reduction of unnecessary biopsies (biopsies in benign lesions) and missed malignancies after recategorising with SWE and SE were the outcome measures. RESULTS: On performing histopathologic evaluation, 368 of 1288 breast masses were malignant. Following the routine B-mode breast ultrasound assessment, 53.80% (495 of 920 patients) underwent an unnecessary biopsy. After recategorising BI-RADS 4a lesions (SWE cut-off ≥3.70 m/s, SE cut-off ≥1.0), 34.78% (320 of 920 patients) underwent an unnecessary biopsy corresponding to a 35.35% (320 versus 495) reduction of unnecessary biopsies. Malignancies in the new BI-RADS 3 cohort were missed in 1.96% (12 of 612 patients). CONCLUSION: Adding combined SWE and SE to routine B-mode breast ultrasound to recategorise BI-RADS 4a patients could help reduce the number of unnecessary biopsies in breast diagnostics by about 35% while keeping the rate of undetected malignancies below the 2% ACR BI-RADS 3 definition.