Mammographic features of benign breast lesions and risk of subsequent breast cancer in women attending breast cancer screening

27 Background: Clinicians often experience difficulty in differentiating benign lesions from invasive breast cancers in patients designated as dense breast. A major limitation of radiological breast cancer screening methods involves a decrease in sensitivity and specificity in women with dense breast. Thus, we sought to test whether Klarify Breast, a combinatorial protein-based biomarker panel could improve early detection of significant breast lesions in a controlled fashion. Clearly, a diagnostic assay that would provide biochemical evidence in the patient’s clinical course is greatly needed. Methods: We have conducted two independent, multi-center, prospective clinical trials to establish the clinical validity of Klarify Breast – an assay that uses multiple Serum Protein Biomarkers (SPBs), Tumor-Associated Autoantibodies (TAAbs), patient specific clinical data and develop a score to differentiate patients with benign breast disease from those with invasive breast cancer. Independent panels of biomarkers and associated algorithms were developed using prospectively collected samples from women under age 50 (n = 351) and from women ages 25-75 (n = 500). Here, we present the benefit of integrating the results of Klarify Breast test with patient imaging to best assess risk in women with dense breast. Results: While performance of the assay was somewhat age dependent (women under the age of 50 demonstrated a higher sensitivity and specificity than women over the age of 50). Here we present data that both groups of women clearly benefit from the addition of a biomarker assay combined with standard of care imaging in identifying invasive breast lesions. Conclusions: Clearly, in women with dense breast, where radiologic studies alone do not permit full assessment in women with a dense breast finding. The biomarker test here, comprised of TAAbs and SPBs, offers a clear advantage in terms of NPV, PPV, Sensitivity and specificity. The results argue strongly for the use of appropriate biomarkers to augment imaging based breast cancer screening in women with dense breast or those who are at high risk. Clinical trial information: NCT01839045, NCT02078570.

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BREAST CANCER SCREENING;

The Professional Medical Journal ◽

10.29309/tpmj/2017.24.01.400 ◽

2017 ◽

Vol 24 (01) ◽

pp. 42-46

Author(s):

Hassan Bukhari ◽

Asim Shaukat ◽

Nosheen Ahmad

Keyword(s):

Breast Cancer ◽

Cancer Screening ◽

High Risk ◽

Diagnostic Accuracy ◽

Breast Cancer Screening ◽

False Negative ◽

Breast Mri ◽

Breast Lesions ◽

True Positive ◽

True Negative

Objectives: To compare the efficacy of Magnetic resonance imaging andMammography for Breast-Cancer Screening in high risk Women with a Familial or GeneticPredisposition. Study Design: Cross-sectional study. Setting: Department of Radiology AlliedHospital, Faisalabad. Duration: From January 2012 to December 2014, Sample size: 299.Methods: A total of 299 females at high risk of breast cancer were included in this study andthey underwent screening rounds of Mammogram and contrast enhanced dynamic breastMRI once a year with independent readings. Both the imaging modalities were interpreted byexperience radiologist and all the images were categorized using Breast Imaging Reportingand Data System. In each patient, histopathology results were considered the standard criteriafor the calculation of the sensitivity, specificity for both Mammogram and Breast MRI lesions.Results: Mean age of the patients was 46.69±11.86 years. Mammography revealed 11 (3.68%)true positive breast lesions, 22 (7.36%) false positive lesion, 247 (82.61%) true negative and19 (6.35%) false negative lesions yielding the sensitivity of 36.67% and diagnostic accuracy of86.3%. Dynamic breast MRI revealed 28 (9.36%) true positive breast lesions with 5 (1.67%) falsepositive, 264 (88.29%) true negative and 2 (0.67%) false negative lesions yielding sensitivity of93.3%,specificity of 98.14%,PPV=84.85%,NPV=99.25% and diagnostic accuracy of 97.66%.MRI breast was significantly more sensitive (93.3 vs. 36.67%) and accurate (97.66 vs. 86.3%)than mammography. Conclusion: MRI is more sensitive than mammography in detectingtumors in women with an inherited susceptibility to breast cancer.

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Evaluation of the FUSION-X-US-II prototype to combine automated breast ultrasound and tomosynthesis

European Radiology ◽

10.1007/s00330-020-07573-3 ◽

2020 ◽

Author(s):

Benedikt Schäfgen ◽

Marija Juskic ◽

Marcus Radicke ◽

Madeleine Hertel ◽

Richard Barr ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Screening ◽

Image Quality ◽

Breast Cancer Screening ◽

Digital Breast Tomosynthesis ◽

Breast Ultrasound ◽

Breast Lesions ◽

Breast Tomosynthesis ◽

Malignant Breast ◽

Automated Breast Ultrasound

Abstract 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® 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. Key Points • The FUSION-X-US-II prototype allows the combination of automated breast ultrasound and digital breast tomosynthesis in a single device without decompression of the breast. • Image quality and coverage of ABUS are sufficient to accurately detect malignant breast lesions. • If tomosynthesis and ABUS should become part of breast cancer screening, the combination of both techniques in one device could offer practical and logistic advantages. To evaluate a potential benefit of a combination of ABUS and tomosynthesis in screening-like settings, further studies are needed.

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