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• This is a general information tool for medical professionals and is not a complete representation of the product(s)’ Instruction for Use (IFU) or Package Insert, and it is the medical professionals’ responsibility to read and follow the IFU or Package Insert. The information provided may suggest a particular technique or protocol however it is the sole responsibility of the medical professional to determine which technique or protocol is appropriate. At all times, clinicians remain responsible for utilizing sound patient evaluation and selection practices, and for complying with applicable local, state, and federal rules and regulations regarding accreditation, anesthesia, reimbursement, and all other aspects of in-office procedures. In no event shall Hologic be liable for damages of any kind resulting from your use of the information presented.

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Introduction to 3D Mammography (Breast Tomosynthesis)

Nomenclature

Shorthand

2D 3D

2D plus 3D 2D plus 3D MLO

Definition

Conventional digital mammography Tomosynthesis A protocol where both digital mammograms and tomosynthesis images are acquired (CC & MLO for both modalities) A protocol where the two-view digital mammogram (CC & MLO) and the tomosynthesis MLO images are acquired

Talk Outline

• What is breast tomosynthesis?

• Why do breast tomosynthesis?

• How does breast tomosynthesis work?

• How do we use it clinically?

• Clinical examples • What is its clinical performance?

• Summary of advantages

What is Breast Tomosynthesis?

• A method of imaging the breast in three dimensions (3D) • Image slices are 1 mm thick • Image slices high resolution: like mammograms

Intended Use Statement

The Hologic Selenia Dimensions Digital Breast Tomosynthesis System generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions system is intended for use in the same clinical applications as Full Field Digital Mammography systems for screening mammograms. Specifically, the Selenia Dimensions system can be used to acquire two-dimensional full field digital mammograms and three-dimensional tomosynthesis mammograms. The screening examination will consist of a two dimensional image set or a two dimensional and tomosynthesis image set. The Selenia Dimensions system may also be used for additional diagnostic workup of the breast.

Mammography Limitations

• Prompt annual mammography has shown the ability to reduce the mortality rate from breast cancer in a population by 15% to 50%.

1-3 • As many as 20% of breast cancers will be missed by mammography.

• Approximately 10% of women are recalled for additional workup and a significant portion prove to have no abnormality, resulting in unnecessary anxiety and cost.

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Smith RA, Duffy SW, Gabe R et al. The randomized trials of breast cancer screening: what have we learned? Radiol Clin N Am 42 (2004) 793 – 806 Hendrick RE, Smith RA, Rutledge JH, Smart CR. Benefit of screening mammography in women ages 40 49: a new meta-analysis of randomized controlled trials. Monogr Natl Cancer Inst 1997;22:87-92.

Tabar L, Vitak B, Tony HH, Yen MF, Duffy SW, Smith RA. Beyond randomized controlled trials: organized mammographic screening substantially reduces breast carcinoma mortality. Cancer 2001;91:1724-31

• A major factor contributing to the limited performance of mammography is the tissue superimposition that is created by the overlap of normal breast structures in a two-dimensional mammographic projection.

• These overlapping structures can obscure a lesion making it more difficult to perceive or rendering it completely mammographically occult.

Why Breast Tomosynthesis (3D mammography)?

• Tissue superimposition hides pathologies in 2D • Tissue superimposition mimics pathologies in 2D

3D Improves Visibility by Reducing Tissue Superimposition

2D Mammogram Tomosynthesis

Better Sensitivity

2D Mammogram Tomosynthesis

Fewer Recalls

How Does Tomosynthesis Work?

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3D Principle of Operation

Arc of motion of x-ray tube, showing individual exposures • • • • X-ray tube moves in an arc across the breast A series of low dose images are acquired from different angles Total dose approximately the same as one 2D mammogram Projection images are reconstructed into 1 mm slices Reconstructed Slices { Compression Paddle Compressed Breast Detector Housing

How is Tomosynthesis Used Clinically?

A collection of publications and presentations documenting the uses and value of breast tomosynthesis is available

Clinical Performance

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Andersson I, Ikeda DM, Zackrisson S, et al. Breast Tomosynthesis and Digital Mammography: A Comparison of Breast Cancer Visibility and BIRADS Classification in a Population of Cancers with Subtle Mammographic Findings. Eur Radiology 18 (12): 2817-25 Gur D, Abrams GS, Chough DM, et al. Digital Breast Tomosynthesis: Observer Performance Study: AJR 2009; 193(2): 586-591.

Kopans D, Moore R, Gavenonis S, Calcification in Digital Breast Tomosynthesis. Presented at RSNA 2008, Session SSJ01-02 Breast Imaging (digital/tomosynthesis) 4 Michell M, et al. Digital Breast Tomosynthesis: A Comparison of the Accuracy of Digital Breast Tomosynthesis, Two-Dimensional Digital Mammography and Two-Dimensional Screening Mammography (Film-Screen). Breast Cancer Research 2009, 11 (Suppl 2):01 5.

Niklason L, Rafferty E, Smith A. Inter-Reader Variability for the Decision to Recall and BIRADS Characterization: Comparing Breast Tomosynthesis Plus FFDM to FFDM Alone. Presented at Duke Tomosynthesis Imaging Symposium May 2009.

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Poplack SP, Tosteson TD, Kogel CH, Nagy HM. Digital Breast Tomosynthesis: Initial Experience in 98 Women with Abnormal Digital Screening Mammography. AJR 2007; 189(3): 616-623

Clinical Performance

7. Rafferty E, Niklason L., Comparison of FFDM with Breast Tomosynthesis to FFDM Alone: Performance in Fatty and Dense Breasts. Presented at Duke Tomosynthesis Imaging Symposium May 2009.

8. EA, Niklason L, Halpern E et al. Assessing Radiologist Performance Using Combined Full Field Digital Mammography and Breast Tomosynthesis Versus Full-Field Digital Mammography Alone: Results of a Multi Center, Multi-Reader Trial. Presented at RSNA 2007, Session SSE26-02 Late Breaking Multicenter Clinical Trials 9.

Rafferty EA, Niklason L, Jameson-Meehan L., Breast Tomosynthesis: One View or Two? Presented at RSNA 2006, Session SSG01-04 Breast Imaging (digital/tomosynthesis.) 10. Teertstra HJ, Loo CE, van den Bosch MAAJ. 12.

Breast Tomosynthesis in Clinical Practice: Initial Results. Eur Radiology 2009 Aug 6. {Epub ahead of print} 11.

Zuley ML, et al. Time to Diagnosis and Performance Levels During Repeat Interpretations of Digital Breast Tomosynthesis. Acad Radiol 2010, Apr, 01: 17(4): 450-5 Svahn T, Adersson I, et al. The Diagnostic Accuracy of Dual-view Digital Mammography, Single-View Breast Tomosynthesis and a Dual-view Combination of Breast Tomosynthesis and Digital Mammography in a Free Response Observe Performance Study. Radiat Prot Dosimetry 2010, Apr, 01: 139(1-3): 113-7

2D Mammogram Tomosynthesis

Better Sensitivity

2D Mammogram Tomosynthesis

Fewer Recalls

Clinical Examples Collected from six sites:

– MGH Boston MA USA – Dartmouth Hitchcock Medical Center, Lebanon NH USA – University of Iowa, Iowa City, IA USA – Magee Women’s Hospital, Pittsburgh PA USA – AVL Cancer Hospital, Amsterdam Holland

Selenia Mammogram Selenia Tomosynthesis Biopsy proven cancer

Selenia Mammogram Selenia Tomosynthesis Mammographically occult biopsy proven cancer

Selenia Mammogram Selenia Tomosynthesis Mammographically occult biopsy proven cancer

Selenia Mammogram Selenia Tomosynthesis Benign. Superimposed parenchyma

Selenia Mammogram Selenia Tomosynthesis Benign. Superimposed parenchyma

Selenia Mammogram Selenia Tomosynthesis Lesion not seen on mammogram

Selenia Mammogram Selenia Tomosynthesis Lesion not seen on mammogram

Pooled ROC Curves

Thank You.

Images and data courtesy of:

Netherlands Cancer Institute – Antoni Van Leeuwenhoek Hospital, Amsterdam Holland Massachusetts General Hospital, Boston MA USA Centre de Radiologie et d’Echographie du Docteur Joussier, Paris France Dartmouth Hitchcock Medical Center, Lebanon NH USA Magee Women’s Hospital, Pittsburgh PA USA University of Iowa Health Care, Iowa City IA USA Yale University School of Medicine, New Haven CT USA