Automated Breast Ultrasonography (ABUS) in the Screening and Diagnostic Setting

Automated breast ultrasonography (ABUS) is a new imaging technology for automatic breast scanning through ultrasound. It was first developed to overcome the limitation of operator dependency and lack of standardization and reproducibility of handheld ultrasound. ABUS provides a three-dimensional representation of breast tissue and allows images reformatting in three planes, and the generated coronal plane has been suggested to improve diagnostic accuracy.

This technique has been first used in the screening setting to improve breast cancer detection, especially in mammographically dense breasts. In recent years, numerous studies also evaluated its use in the diagnostic setting: they showed its suitability for breast cancer staging, evaluation of tumor response to neoadjuvant chemotherapy, and second-look ultrasound after magnetic resonance imaging.

The purpose of this article is to provide a comprehensive review of the current body of literature about the clinical performance of ABUS, summarize available evidence, and identify gaps in knowledge for future research.

Introduction

Handheld ultrasound (HHUS) is an essential diagnostic tool to detect and characterize breast lesions, complementary to digital mammography (DM). In particular, HHUS is mandatory to confirm the finding and to guide biopsy of the suspicious lesion when an abnormality is evidenced on DM (Breast imaging-reporting and data system [BI-RADS] 4–5) .

HHUS can also depict breast cancers, which are at the same time occult on DM, especially in dense breasts (American college of radiology [ACR] BI-RADS breast composition category d), where the sensitivity of DM is lower (47.8%–64.4%) .

However, HHUS is operator-dependent, and in such stetting lacks standardization and reproducibility; it also requires considerable physician time for acquisition. Automated breast ultrasonography (ABUS), also known as automated breast volumetric scanner, has been developed to overcome these limitations. ABUS is a new imaging technology based on automated scanning of the breast using ultrasounds with high-frequency broadband transducers. This provides three-dimensional (3D) representation of breast tissue and allows image reformatting in three planes.

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Technology

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Technique and Interpretation

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Artifacts

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Diagnostic Performance

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TABLE 1

Diagnostic Performance of ABUS

Study author Patients (Lesions, BC) Mean age y (range) SE (%) SP (%) FPR (%) FNR (%) PPV NPV Reference standard Comparative accuracy to HHUS Additional relevant findingsChang N.R. (105, 24) 47±14 (20–79) 92.5 63 37.0 7.5 56.41 93.55 Histology or imaging FUP (mean 11.1±10.4 months, range 0–31 months) N.R. Mean diameter of the lesion, surrounding tissue changes and shape of the mass were the final most important factors associated with lesion detectability.Chang 61 (62, 14) 45

(32-62) 71.4 \* 86.1 \* 14.6 28.6 58.8 91.1 Histology or imaging FUP (mean 15 months, range 15–26 months) N. R. The mean time to interpret the 3D ABUS data per breast was 4.5 minutes (range 3.5–7.5 minutes) for reader 1, 4.0 minutes (range 3.0–7.0 minutes) for reader 2, and 5.5 minutes (range 3.5–9.5 minutes) for reader 3.Chen 175 (219, 67) 41.7 (16-71) 92.5 86.2 13.8 7.5 74.7 96.3 Histology or FUP (not specified) N.S. HHUS: SE 88.1%, SP 87.5%, FPR 12.5%, FNR 11.8%, PPV 75.6%, NPV 94.3% There were significant differences between malignant and benign masses with respect to the retraction phenomenon and hyperechoic rim.Cho 141 (150, 60) 46 (25–71) 98.3 † 70.0 † 30.0 1.7 68.6 98.4 Histology or imaging FUP (mean 20 months, range 12–26 months) N.S. HHUS: SE 96.7%, SP 64.4% Interobserver agreements between the four radiologists for final assessment of solid breast masses were similar for 2D and 3D US images ( P > .05).Golatta 42 (N.R., 20) 51 (33-83) 82.0 68.0 12 12 81.31 69 Histology N. R.Golatta 983 (N.R., 119) 55.7 (19–92) 84.0 85.0 15.0 16.0 27.0 99.0 Combination of HHUS, mammography and histology N.R. Fair agreement (k = 0.25–0.31) of ABUS with HHUS and mammography but total agreement rates for dichotomized (benign versus malignant) lesionsJeh 173 (206, 46) 48 (20-80) 88.05 † \* 76.25 † \* 23.75 ‡ 11.95 ‡ 52.25 ‡ 95.95 ‡ Histology HHUS: SE 95.7% ( P > .05), SP 49.4 ( P < .0001) Smaller lesions and lesions with lower final-assessment category were less frequently detected on ABUS ( P < .011 and P < .0001, respectively).Kim 87 (106, 52) N.R. 89.2 79.0 21.0 10.8 81.31 94.1 Histology or imaging FUP (mean 49 months, range 24–126) N.S. HHUS: SE 98.7%, SP 80.1% Final assessment of solid breast masses showed substantial to almost perfect agreement between HHUS and ABUS (k= 0.773±0.104)Kim 38 (66, 50) N.R. 92.0 87.5 12.5 8.0 95.8 77.8 Histology N.S.HHUS: SE 98.0%, SP 62.5% Overall agreement for mass size, shape, posterior features, orientation and BI-RADS category was moderate while the overall agreement for margins was fair (κ = 0.25)Lin N.R. (35, 15) 40.7 (16–78) 100.0 95.0 5.0 0.0 93.7 100.0 Histology N.S. HHUS: SE 100.0%, SP 85.0% Perfect agreement between ABUS and pathological diagnosis (k=0.942)Kotsianos-Hermle 97 (107, 39) 52.4 (21-78) 96.5 92.3 7.7 3.5 N.R. N.R. Histology N.S.HHUS: SE 97.5%, SP 88.5% Correlation was good between ABUS and HHUS for the BIRADS criterion “margins” (k=0.88)Shin 55 (145, 28) 48 (29–69) 96.0 § 91.8 § 8.2 4.0 N.R. N.R. Combination of HHUS, mammography and histology N.S.HHUS: SE 100.0%, SP 93.0% Lesion detection was reliable (92%) only when mean lesion diameter was>1.2 cmWang 213 (239, 85) 43.0±12.5 (11-81) 95.3 80.5 19.5 4.7 73.0 93.3 Histology N.S.HHUS: SE 90.6%, SP 82.5%Wang 155 (165, 103) 43.1±21.2 (23-65) 96.1 91.9 8.1 3.9 95.2 93.4 Histology N.S.HHUS: SE 93.2%, SP 88.7% The stellate margin had a high specificity (98.4%) but a low sensitivity (57.5%), with an accuracy to determine malignant and benign lesions of 73.9%Wojcinski 50 (50, 14) 52 (32-72) 100 52.8 47.2 0.0 45.2 100.0 HHUSWojcinski 100 (100, 18) 52 (19-86) 83.3 78.1 21.9 16.7 N.R. N.R. HHUSSchmachtenberg 28 (39, 15) 44.6 (26-76) 93.3 83.3 16.7 6.7 77.8 95.2 HHUS, MRI and histology (if available) N.S.HHUS: SE 100.0%, SP 83.3%

BC, Breast cancer; FNR, false negative rate; FPR, false positive rate; FUP, follow-up; HHUS, hand-held ultrasound; N.R., not reported; N.S., not significant ( P > .05); NPV, negative predictive value; PPV, positive predictive value; SE, sensitivity; SP, specificity.

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Interobserver Agreement

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Indications for ABUS

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Screening Setting

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TABLE 2

Studies Comparing Screening Mammography Alone Versus Mammography Plus ABUS

Comparative accuracy (DM+ABUS vs DM alone) Study Study aim Study design Screening US examinations (N°) US-only BC (N°) SE (%) SP (%) DR (per 1000 women screened) RR (per 1000 women screened) Biopsy Rate PPV1 \* (%) PPV2 † (%) PPV3 ‡ (%) Type of cancers detected with additional ABUS screeningBrem To determine the improvement in breast cancer detection using ABUS plus DM versus DM alone in asymptomatic women with dense breasts. Prospective multi-institutional study 15318 30 100% vs 73.2% ( P <.001) 72.0% vs 85.4% ( P <.001) 7.3 vs 5.4 ( P <.001) 284.9 vs 150.2 ( P <.001) 74.3 vs 38.3 ( P <.001) 2.6 vs 3.6 9.5 vs 13.4 9.8 vs 14.0 Invasive (93.3%) and lower stage (66.7% stage IA or IB)Giger To assess and compare radiologist performance in breast cancer detection in women with dense breast tissue using DM alone versus DM plus ABUS Test cancer-enriched set multi-institutional observer study 185 (133 non cancers and 52 biopsy-proven cancers) 31 74.1% vs 57.5% ( P < .001) 76.2% vs 78.1% (N.S.) N.A. N.A. N.A. N.A. N.A. N.A.Giuliano To demonstrate that the adjunct of ABUS increases the detection of non-palpable breast cancers in mammographically dense breasts in asymptomatic women Prospective study 3418 (test group, ABUS+DM) and 4076 (control group, FFDM alone) N.R. 97.67% vs 76.00% ( P <.001) 99.70% vs 98.2% ( P <.001) 12.3 vs 4.6 ( P <.001) N.R. N.R. N.R. N.R. N.R. Invasive (81%), with a mean tumor size of 14.3 mm. 83% Stage 1A and 12% Stage 2A. Node positivity rate 2%Kelly To determine the improvement in diagnostic yield in detecting non-palpable breast cancer in asymptomatic women with ABUS added to DM Prospective multi-institutional study 4419 23 81% vs 40% 98.7% vs 95.15% 7.2 vs 3.6 ( P <.001) 96 vs 42 N.R. N.R. N.R. N.R. 22/23 invasive, 90% smaller than 20 mm and 74% stage 1Wilczek To evaluate the impact of the ABUS when added to DM on breast cancer detection and recall rate in asymptomatic women with dense breasts Prospective study 1668 4 ➢ At study entry: 100% vs 63.6% ( P <.001)

➢ Including interval cancers: 68.8% vs 43.8% (p<0.001) 98.4% vs 99.0% (N.S.) 6.6 vs 4.2 ( P <.001) 22.8 vs 13.8 ( P = .004) 13.8 vs 6.6 ( P <.001) 28.9 vs 30.4 (N.S.) 47.8 vs 63.6 (N.S.) PPV2=PPV3 All invasive, with a mean tumor size of 21.8 mm. 2/4 axillary metastases

DM, full-field digital mammography; DR, detection rate; N.A., not applicable; N.R., not reported; N.S., not significant; PPV, positive predictive value; RR, recall rate; SE, sensitivity; SP, specificity.; US, ultrasound.

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Diagnostic Setting

Lesion Detection and Characterization

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Breast Cancer Staging

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Tumor Size

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Multifocal/Multicentric Disease

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Second Look

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Early Assessment of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

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Limitations and Practical Drawbacks

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Future Perspectives

Follow-up of Benign Lesions

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Breast Density Analysis

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Molecular Subtypes of Breast Cancer

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Conclusion

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Automated Breast Ultrasonography (ABUS) in the Screening and Diagnostic Setting

Introduction

Technology

Technique and Interpretation

Artifacts

Diagnostic Performance

Interobserver Agreement

Indications for ABUS

Screening Setting

Diagnostic Setting

Lesion Detection and Characterization

Breast Cancer Staging

Tumor Size

Multifocal/Multicentric Disease

Second Look

Early Assessment of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

Limitations and Practical Drawbacks

Future Perspectives

Follow-up of Benign Lesions

Breast Density Analysis

Molecular Subtypes of Breast Cancer

Conclusion

References

Further Reading

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