AJR:211, September 2018 689 mography versus its benefts [2]. Gray-scale ultrasound is the most frequently used diag- nostic imaging modality after mammography [3, 4]. Imaging and interpretive strategies have been developed that enable high sensitivities to be achieved when breast ultrasound is used Downgrading and Upgrading Gray-Scale Ultrasound BI-RADS Categories of Benign and Malignant Masses With Optoacoustics: A Pilot Study Erin I. Neuschler 1 Philip T. Lavin 2 F. Lee Tucker 3 Lora D. Barke 4 Margaret L. Bertrand 5 Marcela Böhm-Vélez 6 Stamatia Destounis 7 Basak E. Dogan 8,9 Stephen R. Grobmyer 10 Janine Katzen 11 Kenneth A. Kist 12 Erini V. Makariou 13 Tchaiko M. Parris 14 Catherine A. Young 15,16 Reni Butler 17 Neuschler EI, Lavin PT, Tucker FL, et al. Women’s Imaging • Original Research This article is available for credit. AJR 2018; 211:689–700 0361–803X/18/2113–689 © American Roentgen Ray Society T here is evidence that early detec- tion of breast cancer from screen- ing mammography saves lives [1]. However, there has been recent pushback against breast cancer screening by groups that accentuate the harms of mam- Keywords: BI-RADS, breast cancer, breast ultrasound, optoacoustic imaging, photoacoustic imaging doi.org/10.2214/AJR.17.18436 Received April 30, 2017; accepted after revision February  7, 2018. Based on presentations at the ARRS 2016 (Los Angeles, CA) and 2017 (New Orleans, LA) Annual Meetings; the Radiological Society of North America 2013 and 2015 annual meetings, Chicago, IL; and the European Congress of Radiology 2015 annual meeting, Vienna, Austria. F. L. Tucker has a research contract with Seno Medical Instruments, Inc. to provide central pathology review and histopathology analysis services. B. E. Dogan has a research grant from GE Healthcare. S. R. Grobmyer has received research funding from Provista Diagnostics and Mitaka US. E. I. Neuschler, P. T. Lavin, F. L. Tucker, L. D. Barke, M. L. Bertrand, M. Böhm-Vélez, B. E. Dogan, S. R. Grobmyer, J. Katzen, K. A. Kist, E. V. Makariou, C. A. Young, and R. Butler had travel expenses related to training and research meetings paid by Seno Medical Instruments, Inc. Northwestern University Feinberg School of Medicine, Weinstein Imaging Associates, Elizabeth Wende Breast Care, MD Anderson Cancer Center, the Cleveland Clinic, Weill Cornell Medicine, UT Health San Antonio, MedStar Georgetown University Hospital, Radnet, Austin Radiological Association, and Yale School of Medicine had research grants from Seno Medical Instruments, Inc. Boston Biostatistics Research Foundation has a research contract with Seno Medical Instruments, Inc. to provide study design and analysis services. Radiologic Imaging Associates, P.C., received funds from Seno Medical Instruments, Inc. for the conduct of the study at their site. Solis Mammogra- phy Greensboro was compensated for expenses related to the Seno research. 1 Department of Radiology, Northwestern University Feinberg School of Medicine, 676 N St Clair St, Ste 800, Chicago, IL 60611. Address correspondence to E. I. Neuschler (Erin.Neuschler@nm.org). 2 Boston Biostatistics Research Foundation, Framingham, MA. 3 Virginia Biomedical Laboratories, LLC, Wirtz, VA. 4 Radiologic Imaging Associates, Englewood, CO. 5 Solis Mammography Greensboro, Greensboro, NC. 6 Weinstein Imaging Associates, Pittsburgh, PA. 7 Elizabeth Wende Breast Care, Rochester, NY. 8 Department of Radiology and Breast Imaging, MD Anderson Cancer Center, Houston, TX. 9 Present address: Department of Radiology, UT Southwestern Medical Center, Dallas, TX. 10 Cleveland Clinic, Cleveland, OH. 11 Department of Radiology, Weill Cornell Medicine, New York, NY. 12 UT Health San Antonio, San Antonio, TX. 13 Department of Radiology, MedStar Georgetown University Hospital, Washington, DC. 14 Breastlink Temecula Valley, Murrieta, CA. 15 Austin Radiological Association, Austin, TX. 16 Present address: Mallinckrodt Institute of Radiology, Washington University School of Medicine in St. Louis, St. Louis, MO. 17 Department of Radiology and Biomedical Imaging, Yale-New Haven Hospital/Smilow Cancer Hospital, New Haven, CT. OBJECTIVE. False-positive fndings remain challenging in breast imaging. This study investigates the incremental value of optoacoustic imaging in improving BI-RADS categori- zation of breast masses at ultrasound. SUBJECTS AND METHODS. The study device is an optoacoustic breast imaging de- vice with a handheld duplex laser and internal gray-scale ultrasound probe, fusing functional and morphologic information (optoacoustic ultrasound). In this prospective multisite study, breast masses assessed as BI-RADS category 3, 4A, 4B, 4C, or 5 by site radiologists under- went both gray-scale ultrasound and optoacoustic imaging with the study device. Indepen- dent reader radiologists assessed internal gray-scale ultrasound and optoacoustic ultrasound features for each mass and assigned a BI-RADS category. The percentage of mass reads for which optoacoustic ultrasound resulted in a downgrade or upgrade of BI-RADS category rel- ative to internal gray-scale ultrasound was determined. RESULTS. Of 94 total masses, 39 were biopsy-proven malignant, 44 were biopsy-proven benign, and 11 BI-RADS category 3 masses were stable at 12-month follow-up. The sensitiv- ity of both optoacoustic ultrasound and internal gray-scale ultrasound was 97.1%. The speci- fcity was 44.3% for optoacoustic ultrasound and 36.4% for internal gray-scale ultrasound. Using optoacoustic ultrasound, 41.7% of benign masses or BI-RADS category 3 masses that were stable at 12-month follow-up were downgraded to BI-RADS category 2 by independent readers; 36.6% of masses assigned BI-RADS category 4A were downgraded to BI-RADS category 3 or 2, and 10.1% assigned BI-RADS category 4B were downgraded to BI-RADS category 3 or 2. Using optoacoustic ultrasound, independent readers upgraded 75.0% of the malignant masses classifed as category 4A, 4B, 4C, or 5, and 49.4% of the malignant masses were classifed as category 4B, 4C, or 5. CONCLUSION. Optoacoustic ultrasound resulted in BI-RADS category downgrading of benign masses and upgrading of malignant masses compared with gray-scale ultrasound. Neuschler et al. Optoacoustic Versus Gray-Scale Ultrasound of Breast Masses Women’s Imaging Original Research Downloaded from www.ajronline.org by 18.206.238.209 on 11/03/21 from IP address 18.206.238.209. Copyright ARRS. For personal use only; all rights reserved