Prospective assessment of adjunctive ultrasound-guided diffuse optical tomography in women undergoing breast biopsy: Impact on BI-RADS assessments.

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.