Steven P Poplack1, Catherine A Young2, Ian S Hagemann3, Jingqin Luo4, Cheryl R Herman5, Kimberly Wiele6, Shuying Li7, Yifeng Zeng8, Matthew F Covington9, Quing Zhu10. 1. Stanford School of Medicine, Center for Academic Medicine, Radiology + MC: 5659, 453 Quarry Road, Palo Alto, CA 94304, United States. Electronic address: spoplack@stanford.edu. 2. Texas A&M College of Medicine, Round Rock, TX, 78665, United States. Electronic address: Catherine.young@BSWHealth.org. 3. Washington University School of Medicine, 425 S. Euclid Ave., Campus Box 8118, St. Louis, MO 63110, United States. Electronic address: hagemani@wustl.edu. 4. Biostatistics Shared Resource, Siteman Cancer Center, Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, Saint Louis, MO 63110, United States. Electronic address: jingqinluo@wustl.edu. 5. Washington University School of Medicine, 510 South Kingshighway Blvd., Campus Box 8131, Saint Louis, MO 63110, United States. Electronic address: hermanc@wustl.edu. 6. Washington University School of Medicine, 510 South Kingshighway Blvd., Campus Box 8131, Saint Louis, MO 63110, United States. Electronic address: wielek@wustl.edu. 7. Department of Biomedical Engineering, Washington University in St. Louis, 1 Brookings Dr, St. Louis, MO 63130, United States. Electronic address: lishuying@wustl.edu. 8. Department of Biomedical Engineering, Washington University in St. Louis, 1 Brookings Dr, St. Louis, MO 63130, United States. Electronic address: yifeng.zeng@wustl.edu. 9. Center for Quantitative Cancer Imaging, Huntsman Cancer Institute, Department of Radiology and Imaging Sciences, University of Utah, 2000 Circle of Hope, Salt Lake City, UT 84112, United States. Electronic address: matthew.covington@hsc.utah.edu. 10. Washington University in St. Louis, Department of Biomedical Engineering, Washington University in St. Louis, 1 Brookings Dr, Mail Box 1097, St. Louis, MO 63130, United States. Electronic address: zhu.q@wustl.edu.
Abstract
PURPOSE: To assess the impact of adjunctive ultrasound guided diffuse optical tomography (US-guided DOT) on BI-RADS assessment in women undergoing US-guided breast biopsy. METHOD: This prospective study enrolled women referred for US-guided breast biopsy between 3/5/2019 and 3/19/2020. Participants underwent US-guided DOT immediately before biopsy. The US-guided DOT acquisition generated average maximum total hemoglobin (HbT) spatial maps and quantitative HbT values. Four radiologists blinded to histopathology assessed conventional imaging (CI) to assign a CI BI-RADS assessment and then integrated DOT information in assigning a CI&DOT BI-RADS assessment. HbT was compared between benign and malignant lesions using an ANOVA test and Tukey's test. Benign biopsies were tabulated, deeming BI-RADS ≥ 4A as positive. Reader agreement was assessed. RESULTS: Among 61 included women (mean age 48 years), biopsy demonstrated 15 (24.6%) malignant and 46 (75.4%) benign lesions. Mean HbT was 55.3 ± 22.6 µM in benign lesions versus 85.4 ± 15.6 µM in cancers (p < .001). HbT threshold of 78.5 µM achieved sensitivity 80% (12/15) and specificity 89% (41/46) for malignancy. Across readers and patients, 197 pairs of CI BI-RADS and CI&DOT BI-RADS assessments were assigned. Adjunctive US-guided DOT achieved a net decrease in 23.5% (31/132) of suspicious (CI BI-RADS ≥ 4A) assessments of benign lesions (34 correct downgrades and 3 incorrect upgrades). 38.3% (31/81) of 4A assessments were appropriately downgraded. No cancer was downgraded to a non-actionable assessment. Interreader agreement analysis demonstrated kappa = 0.48-0.53 for CI BI-RADS and kappa = 0.28-0.44 for CI&DOT BI-RADS. CONCLUSIONS: Integration of US-guided DOT information achieved a 23.5% reduction in suspicious BI-RADS assessments for benign lesions. Larger studies are warranted, with attention to improved reader agreement.
PURPOSE: To assess the impact of adjunctive ultrasound guided diffuse optical tomography (US-guided DOT) on BI-RADS assessment in women undergoing US-guided breast biopsy. METHOD: This prospective study enrolled women referred for US-guided breast biopsy between 3/5/2019 and 3/19/2020. Participants underwent US-guided DOT immediately before biopsy. The US-guided DOT acquisition generated average maximum total hemoglobin (HbT) spatial maps and quantitative HbT values. Four radiologists blinded to histopathology assessed conventional imaging (CI) to assign a CI BI-RADS assessment and then integrated DOT information in assigning a CI&DOT BI-RADS assessment. HbT was compared between benign and malignant lesions using an ANOVA test and Tukey's test. Benign biopsies were tabulated, deeming BI-RADS ≥ 4A as positive. Reader agreement was assessed. RESULTS: Among 61 included women (mean age 48 years), biopsy demonstrated 15 (24.6%) malignant and 46 (75.4%) benign lesions. Mean HbT was 55.3 ± 22.6 µM in benign lesions versus 85.4 ± 15.6 µM in cancers (p < .001). HbT threshold of 78.5 µM achieved sensitivity 80% (12/15) and specificity 89% (41/46) for malignancy. Across readers and patients, 197 pairs of CI BI-RADS and CI&DOT BI-RADS assessments were assigned. Adjunctive US-guided DOT achieved a net decrease in 23.5% (31/132) of suspicious (CI BI-RADS ≥ 4A) assessments of benign lesions (34 correct downgrades and 3 incorrect upgrades). 38.3% (31/81) of 4A assessments were appropriately downgraded. No cancer was downgraded to a non-actionable assessment. Interreader agreement analysis demonstrated kappa = 0.48-0.53 for CI BI-RADS and kappa = 0.28-0.44 for CI&DOT BI-RADS. CONCLUSIONS: Integration of US-guided DOT information achieved a 23.5% reduction in suspicious BI-RADS assessments for benign lesions. Larger studies are warranted, with attention to improved reader agreement.
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