Bianca den Dekker, MD - PhD student. Prof dr R.M. Pijnappel Prof dr H.M. Verkooijen Dr M. Broeders
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1 Diagnostic value of Three-dimensional UltRasound in breast cancer screening participants referred with a BI-RADS 0 test result: a comparison of imaging strategies (TURBO) Bianca den Dekker, MD - PhD student Prof dr R.M. Pijnappel Prof dr H.M. Verkooijen Dr M. Broeders
2 Breast density High breast density reduces sensitivity of mammography¹ High breast density is a risk factor for breast cancer² 1. Boyd, N.F., et al., Mammographic density and the risk and detection of breast cancer. N Engl J Med, (3): p Pisano, E.D., et al., Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med, (17): p
3 Breast Ultrasound High inter-observer variability Time consuming 3-Dimensional Automated Breast Ultrasound
4 Invenia ABUS
5 Invenia ABUS
6
7 Invenia ABUS
8 Advantages 3D ABUS Standardized image acquisition protocol Image acquisition by technician Digital storage Enables re-evaluation, double reading, CAD³ 3. van Zelst, J.C., et al., Improved cancer detection in automated breast ultrasound by radiologists using Computer Aided Detection. Eur J Radiol, : p
9 SomoInsight Study⁴ Design: Multicenter observational study Population: women, mean age 53.3, with heterogeneously (50-75%) or extremely (>75%) dense breasts Addition of ABUS to screening mammography 4. Brem, R.F., et al., Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study. Radiology, (3): p
10 SomoInsight Study⁴ Design: Multicenter observational study Population: women, mean age 53.3, with heterogeneously (50-75%) or extremely (>75%) dense breasts Addition of ABUS to screening mammography Results Additional 1.9 detected cancers per 1000 (95% CI , p-value <0.001) 93.3% of additional cancers were invasive Increase in recall rate per 1000 (95% CI , p-value <0.001) 4. Brem, R.F., et al., Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study. Radiology, (3): p
11 EASY Study⁵ Design: single center observational study Population: asymptomatic women, mean age 49.5, with heterogeneously (50-75%) or extremely (>75%) dense breasts Addition of ABUS to mammography 5. Wilczek et al. Adding 3D Automated Breast Ultrasound to mammography screening in women with heterogeneously and extremely dense breasts. Report from a hospital-based, high-volume, single-center breast cancer screening program. European Journal of Radiology 85 (2016)
12 EASY Study⁵ Design: single center observational study Population: asymptomatic women, mean age 49.5, with heterogeneously (50-75%) or extremely (>75%) dense breasts Addition of ABUS to mammography Results Additional 2.4 detected cancers per % CI , p-value < Additional 9.0 recalls per % CI , p-value Wilczek et al. Adding 3D Automated Breast Ultrasound to mammography screening in women with heterogeneously and extremely dense breasts. Report from a hospital-based, high-volume, single-center breast cancer screening program. European Journal of Radiology 85 (2016)
13 Rationale TURB0 study BI-RADS 0 referral 88% false positive result⁶ 20% undergoes invasive diagnostic procedures⁶ Optimize the imaging strategy in women referred with a BI-RADS 0 result 6. Monitor bevolkingsonderzoek borstkanker juli 2017 via 965e-466f-afb4-9a823c5a41be&type=pdf&disposition=inline
14 Objective TURB0 study To investigate the diagnostic accuracy of 3DUS as a standalone imaging modality as well as in combination with conventional imaging modalities to diagnose breast cancer in Dutch breast cancer screening participants referred with a BI-RADS 0 mammography result.
15 Objective TURB0 study To investigate the diagnostic accuracy of 3DUS as a standalone imaging modality as well as in combination with conventional imaging modalities to diagnose breast cancer in Dutch breast cancer screening participants referred with a BI-RADS 0 mammography result. Secondary objectives To investigate the diagnostic accuracy among subgroups of patients based on mammographic density and age. To determine the biopsy referral rate for the different imaging strategies. To assess the interobserver reliability for 3DUS.
16 Study design Multicenter diagnostic study
17 Study design Multicenter diagnostic study Participating hospitals Elisabeth TweeSteden Ziekenhuis Tilburg Rijnstate Ziekenhuis Arnhem Catharina Ziekenhuis Eindhoven
18 Study design Multicenter diagnostic study Participating hospitals Elisabeth TweeSteden Ziekenhuis Tilburg Rijnstate Ziekenhuis Arnhem Catharina Ziekenhuis Eindhoven Study population: Dutch breast cancer screening participants with a BI-RADS 0 mammography result, who are referred to one of the participating hospitals for further diagnostic work-up Sample size: 600
19
20 Reader study Independent assessment of different imaging strategies 3D ABUS Tomosynthesis + HHUS ( current practice ) Tomosynthesis + 3D ABUS Tomosynthesis + HHUS + 3D ABUS
21 Planning Time period April 2018 October 2019 End of 2019 End of 2021 Activities Patient inclusion Data collection First results (histopathological outcome) Final results (follow up outcome)
22 B.M. den Dekker Department of Radiology UMC Utrecht Q PO box 85500, 3508 GA Utrecht
Ruud Pijnappel Professor of Radiology, UMC Utrecht. Chair Dutch Expert Centre for Screening Board EUSOBI
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Meeting of the Radiological Devices Advisory Panel On October 24, 22, the panel will discuss, make recommendations, and vote on a premarket approval application supplement (P83/S) to expand the indications
Disclosures. Breast Cancer. Breast Imaging Modalities. Breast Cancer Screening. Breast Cancer 6/4/2014
: Information for the Primary Care Physician Disclosures No financial relationships with commercial entities producing health care products/services. Roxsann Roberts, MD Section Chief, MRI Erlanger/EmCare