A New Practical Decision Rule to Better Differentiate BI-RADS© 3 or 4 Breast Masses on Breast Ultrasound.
BI-RADS; breast mass; decision rule; malignancy; reliability; ultrasound; BI-RADS; breast mass; decision rule; malignancy; reliability; ultrasound
Objectives: The BI-RADS© classification provides a standardized way to describe ultrasound findings in breast cancer diagnostics. However, there is little information regarding which BI-RADS© descriptors are most strongly associated with malignancy, to better distinguish BI-RADS© 3 (follow-up imaging) and 4 (diagnostic biopsy) breast masses.; Methods: Patients were recruited as part of an international, multicenter trial (NCT02638935). The trial enrolled 1294 women (6 excluded) categorized as BI-RADS© 3 or 4 upon routine B-mode ultrasound examination. Ultrasound images were evaluated by three expert physicians according to BI-RADS©. All patients underwent histopathological confirmation (reference standard). We performed univariate and multivariate analyses (chi-square test, logistic regression, and Krippendorff's alpha).; Results: Histopathologic evaluation showed malignancy in 368 of 1288 masses (28.6%). Upon performing multivariate analysis, the following descriptors were significantly associated with malignancy (P < .05): age ≥50 years (OR 8.99), non-circumscribed indistinct (OR 4.05) and microlobulated margin (OR 2.95), nonparallel orientation (OR 2.69), and calcification (OR 2.64). A clinical decision rule informed by these results demonstrated a 97% sensitivity and missed fewer cancers compared to three physician experts (range of sensitivity 79-95%) and a previous decision rule (sensitivity 59%). Specificity was 44% versus 22-83%, respectively. The inter-reader reliability of the BI-RADS© descriptors and of the final BI-RADS© score was fair-moderate.; Conclusions: A patient should undergo a diagnostic biopsy (BI-RADS© 4) instead of follow-up imaging (BI-RADS© 3) if the patient is 50 years or older or exhibits at least one of the following features: calcification, nonparallel orientation of mass, non-circumscribed margin, or posterior shadowing. (© 2021 The Authors. Journal of Ultrasound in Medicine published by Wiley Periodicals LLC on behalf of American Institute of Ultrasound in Medicine.)
Pfob A; Barr RG; Duda V; Büsch C; Bruckner T; Spratte J; Nees J; Togawa R; Ho C; Fastner S; Riedel F; Schaefgen B; Hennigs A; Sohn C; Heil J; Golatta M
Journal Of Ultrasound In Medicine
2021
2021-05-04
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
journalArticle
<a href="http://doi.org/10.1002/jum.15722" target="_blank" rel="noreferrer noopener">10.1002/jum.15722</a>
Evaluation of the FUSION-X-US-II prototype to combine automated breast ultrasound and tomosynthesis
Imaging; Ultrasonography; Mammography; mammary; Early detection of cancer; Multimodal imaging; three-dimensional
Objective The FUSION-X-US-II prototype was developed to combine 3D automated breast ultrasound (ABUS) and digital breast tomosynthesis in a single device. We evaluated the performance of ABUS and tomosynthesis in a single examination in a clinical setting. Methods In this prospective feasibility study, digital breast tomosynthesis and ABUS were performed using the FUSION-X-US-II prototype without any change of the breast position in patients referred for clarification of breast lesions with an indication for tomosynthesis. The tomosynthesis and ABUS images of the prototype were interpreted independently from the clinical standard by a breast diagnostics specialist. Any detected lesion was classified using BI-RADS (R) scores, and results of the standard clinical routine workup (gold standard) were compared to the result of the separate evaluation of the prototype images. Image quality was rated subjectively and coverage of the breast was measured. Results One hundred one patients received both ABUS and tomosynthesis using the prototype. The duration of the additional ABUS acquisition was 40 to 60 s. Breast coverage by ABUS was approximately 80.0%. ABUS image quality was rated as diagnostically useful in 86 of 101 cases (85.1%). Thirty-three of 34 malignant breast lesions (97.1%) were identified using the prototype. Conclusion The FUSION-X-US-II prototype allows a fast ABUS scan in combination with digital breast tomosynthesis in a single device integrated in the clinical workflow. Malignant breast lesions can be localized accurately with direct correlation of ABUS and tomosynthesis images. The FUSION system shows the potential to improve breast cancer screening in the future after further technical improvements.
Schaefgen B; Juskic M; Radicke M; Hertel M; Barr R; Pfob A; Togawa R; Nees J; von Au A; Fastner S; Harcos A; Gomez C; Stieber A; Riedel F; Hennigs A; Sohn C; Heil J; Golatta M
European Radiology
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
journalArticle
<a href="http://doi.org/10.1007/s00330-020-07573-3" target="_blank" rel="noreferrer noopener">10.1007/s00330-020-07573-3</a>
Initial results of the FUSION-X-US prototype combining 3D automated breast ultrasound and digital breast tomosynthesis
Breast; cancer; cancer; combination; dense breasts; future; hhus; Mammography; Multimodal Imaging; Nuclear Medicine & Medical Imaging; program; Radiology; screening mammography; therapy; Ultrasonography; volume; women
To determine the feasibility of a prototype device combining 3D-automated breast ultrasound (ABVS) and digital breast tomosynthesis in a single device to detect and characterize breast lesions. In this prospective feasibility study, the FUSION-X-US prototype was used to perform digital breast tomosynthesis and ABVS in 23 patients with an indication for tomosynthesis based on current guidelines after clinical examination and standard imaging. The ABVS and tomosynthesis images of the prototype were interpreted separately by two blinded experts. The study compares the detection and BI-RADSA (R) scores of breast lesions using only the tomosynthesis and ABVS data from the FUSION-X-US prototype to the results of the complete diagnostic workup. Image acquisition and processing by the prototype was fast and accurate, with some limitations in ultrasound coverage and image quality. In the diagnostic workup, 29 solid lesions (23 benign, including three cases with microcalcifications, and six malignant lesions) were identified. Using the prototype, all malignant lesions were detected and classified as malignant or suspicious by both investigators. Solid breast lesions can be localized accurately and fast by the Fusion-X-US system. Technical improvements of the ultrasound image quality and ultrasound coverage are needed to further study this new device. The prototype combines tomosynthesis and automated 3D-ultrasound (ABVS) in one device. It allows accurate detection of malignant lesions, directly correlating tomosynthesis and ABVS data. The diagnostic evaluation of the prototype-acquired data was interpreter-independent. The prototype provides a time-efficient and technically reliable diagnostic procedure. The combination of tomosynthesis and ABVS is a promising diagnostic approach.
Schaefgen B; Heil J; Barr R G; Radicke M; Harcos A; Gomez C; Stieber A; Hennigs A; Von Au A; Spratte J; Rauch G; Rom J; Schutz F; Sohn C; Golatta M
European Radiology
2018
2018-06
Journal Article
<a href="http://doi.org/10.1007/s00330-017-5235-8" target="_blank" rel="noreferrer noopener">10.1007/s00330-017-5235-8</a>