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2. Introduction to 3D Mammography (Breast Tomosynthesis)

3. Nomenclature Shorthand Definition 2D Conventional digital mammography
Tomosynthesis
2D plus 3D
A protocol where both digital mammograms and tomosynthesis images are acquired (CC & MLO for both modalities)
2D plus 3D MLO
A protocol where the two-view digital mammogram (CC & MLO) and the tomosynthesis MLO images are acquired
First a word about nomenclature. Throughout this presentation we will refer to 2D and to 3D imaging. 2D refers to standard digital mammography, and 3D is a shorthand that refers to tomosynthesis imaging. When we refer to 2D plus 3D imaging we are talking about a protocol where both digital mammograms and tomosynthesis images are acquired, both CC & MLO for both modalities. Similarly, 2D plus 3D-MLO is a protocol where CC & MLO digital mammograms and the tomosynthesis MLO images are acquired.

4. 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

5. 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

6. 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.

7. 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.
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:

8. 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.

9. Why Breast Tomosynthesis (3D mammography)?
Tissue superimposition hides pathologies in 2D
Tissue superimposition mimics pathologies in 2D

10. 3D Improves Visibility by Reducing Tissue Superimposition

11. Better Sensitivity 2D Mammogram Tomosynthesis
Example of false negative for mammography, resolved by tomosynthesis. This woman had her regular screening mammogram (on the left), which was rated as BI-RADS 1, or normal. Some weeks later she returned because of a palpable lump in her breast. Ultrasound detected this lump and was determined through biopsy to be DCIS. Her mammogram was retrospectively reviewed and the cancer was deemed to be mammographically occult. On review of the tomosynthesis image on the right, the cancer can be clearly seen near the skin line above the nipple. The tomo image was taken at the same time as the mammogram, but because of the clinical protocol involving the non-FDA approved device, the tomo images were, unfortunately for the patient, not reviewed at the time of acquisition.
Better Sensitivity

12. Fewer Recalls 2D Mammogram Tomosynthesis
Example of false positive for mammography, resolved by tomosynthesis. The object circled on the mammogram was highly suspicious for malignancy. The structure was seen in both the MLO and CC views, and persisted on the multiple diagnostic mammograms. The patient underwent biopsy and the structure was benign. If you look at the corresponding tomosynthesis images in the area, you see nothing malignant. The structure seen in the mammogram was the result of overlapping tissues. Diagnosis was given as superimposed parenchyma.
This image also has some nice skin calcifications seen in the tomosynthesis slices near the breast paddle. The calcs can be seen in the digital mammogram as well, but in the tomo images their three dimensional location inside the breast is determined, and they can be seen to reside within a few mm of the skin surface.
Fewer Recalls

13. How Does Tomosynthesis Work?

15. 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
Compression Paddle
Reconstructed Slices {
Compressed Breast
Detector Housing

16. How is Tomosynthesis Used Clinically?
A collection of publications and presentations documenting the uses and value of breast tomosynthesis is available

17. Clinical Performance
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):
Gur D, Abrams GS, Chough DM, et al. Digital Breast Tomosynthesis: Observer Performance Study: AJR 2009; 193(2):
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
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.
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):

18. 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
Rafferty EA, Niklason L, Jameson-Meehan L., Breast Tomosynthesis: One View or Two? Presented at RSNA 2006, Session SSG Breast Imaging (digital/tomosynthesis.)
10. Teertstra HJ, Loo CE, van den Bosch MAAJ. Breast Tomosynthesis in Clinical Practice: Initial Results. Eur Radiology 2009 Aug 6. {Epub ahead of print}
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

19. Better Sensitivity 2D Mammogram Tomosynthesis
Example of false negative for mammography, resolved by tomosynthesis. This woman had her regular screening mammogram (on the left), which was rated as BI-RADS 1, or normal. Some weeks later she returned because of a palpable lump in her breast. Ultrasound detected this lump and was determined through biopsy to be DCIS. Her mammogram was retrospectively reviewed and the cancer was deemed to be mammographically occult. On review of the tomosynthesis image on the right, the cancer can be clearly seen near the skin line above the nipple. The tomo image was taken at the same time as the mammogram, but because of the clinical protocol involving the non-FDA approved device, the tomo images were, unfortunately for the patient, not reviewed at the time of acquisition.
Better Sensitivity

20. Fewer Recalls 2D Mammogram Tomosynthesis
Example of false positive for mammography, resolved by tomosynthesis. The object circled on the mammogram was highly suspicious for malignancy. The structure was seen in both the MLO and CC views, and persisted on the multiple diagnostic mammograms. The patient underwent biopsy and the structure was benign. If you look at the corresponding tomosynthesis images in the area, you see nothing malignant. The structure seen in the mammogram was the result of overlapping tissues. Diagnosis was given as superimposed parenchyma.
This image also has some nice skin calcifications seen in the tomosynthesis slices near the breast paddle. The calcs can be seen in the digital mammogram as well, but in the tomo images their three dimensional location inside the breast is determined, and they can be seen to reside within a few mm of the skin surface.
Fewer Recalls

21. 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

22. Selenia Mammogram
Selenia Tomosynthesis
Biopsy proven cancer

23. Mammographically occult biopsy proven cancer
Selenia Mammogram
Selenia Tomosynthesis
Mammographically occult biopsy proven cancer

24. Mammographically occult biopsy proven cancer
Selenia Mammogram
Selenia Tomosynthesis
Example of false negative for mammography, resolved by tomosynthesis. This woman had her regular screening mammogram (on the left), which was rated as BI-RADS 1, or normal. Some weeks later she returned because of a palpable lump in her breast. Ultrasound detected this lump and was determined through biopsy to be DCIS. Her mammogram was retrospectively reviewed and the cancer was deemed to be mammographically occult. On review of the tomosynthesis image on the right, the cancer can be clearly seen near the skin line above the nipple. The tomo image was taken at the same time as the mammogram, but because of the clinical protocol involving the non-FDA approved device, the tomo images were, unfortunately for the patient, not reviewed at the time of acquisition.
Mammographically occult biopsy proven cancer

25. Benign. Superimposed parenchyma
Selenia Mammogram
Selenia Tomosynthesis
Benign. Superimposed parenchyma

26. Benign. Superimposed parenchyma
Selenia Mammogram
Selenia Tomosynthesis
Example of false positive for mammography, resolved by tomosynthesis. The object circled on the mammogram was highly suspicious for malignancy. The structure was seen in both the MLO and CC views, and persisted on the multiple diagnostic mammograms. The patient underwent biopsy and the structure was benign. If you look at the corresponding tomosynthesis images in the area, you see nothing malignant. The structure seen in the mammogram was the result of overlapping tissues. Diagnosis was given as superimposed parenchyma.
This image also has some nice skin calcifications seen in the tomosynthesis slices near the breast paddle. The calcs can be seen in the digital mammogram as well, but in the tomo images their three dimensional location inside the breast is determined, and they can be seen to reside within a few mm of the skin surface.
Benign. Superimposed parenchyma

27. Lesion not seen on mammogram
Selenia Mammogram
Selenia Tomosynthesis
Lesion not seen on mammogram

28. Lesion not seen on mammogram
Selenia Mammogram
Selenia Tomosynthesis
Example of false positive for mammography, resolved by tomosynthesis. There was a circular lesion clearly seen in the CC mammogram (not shown) but not visible on the MLO mammogram. This object was biopsied under ultrasound and found to be benign. In the MLO tomosynthesis image (and on the CC tomo not shown) the object comes into focus very clearly. Its margins can be clearly seen and the object is a benign fat containing mass. The radiologist felt that he would not have gone on the biopsy or even diagnostic mammography if the tomo images had been available for use in the diagnosis.
Lesion not seen on mammogram

29. Pooled ROC Curves

30. 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