1. Mammography QA Solutions
Confidential – Subject to Distributor Confidentiality Agreement
Mammography QA Solutions
Global Distributor Training: DIAGNOSTIC MAMMOGRAPHY
March, 2016

2. The Gold Standard in Breast Health
Outline
Market
Technology
QA Requirements
Mammography Phantoms
Training Phantoms & Accessories
Competition
Mammography Kits
Full Field Digital Mammography (FFDM) Phantom
Tomosynthesis Phantom Development
Mammo 156™ Phantom
The Gold Standard in Breast Health
Confidential

3. Global Market Mammography systems: $610M by 2018*
Europe: largest market
Asia-Pacific: fastest-growing
10% annual growth projected by 2018**.
US accredited mammography units: 13,979
Gammex (RMI) is the global leader
in Mammography QA Phantom sales: > 11,400 sold
Gammex’s Mammo 156™ Phantom is the Gold Standard
Key countries include US, Canada, the UK, Germany, France, Italy, Spain, Japan, China, India, Australia and Brazil.**
Total breast imaging market growing a 5% to ~$5B by 2017 (include MRI, Ultrasound, PET, CT, Nuclear Medicine etc.)**
USA certified* facilities: 8,745
USA accredited mammography units: 13,979
USA certified* facilities with FFDM units: 8,320
USA accredited FFDM units: 13,428
Mammograms performed annually (USA) in aggregate: 38,770,390
*Global Industry Analysts, Inc.
**KLAS
Confidential
*GBI Research
**Markets and Markets
***Global Industry Analysts, Inc.
****KLAS
+ACR communication direct with Gammex

4. Technology Hologic GE Mammography Mammogram Stereotactic Biopsy
X-rays used to diagnose and locate tumors
Mammogram
Radiographic image of the breast used to screen for breast cancer
X-ray beam, compression plates, camera
Stereotactic Biopsy
Mammogram + target localization
Biopsy
Tomosynthesis (DBT)
Advanced digital mammography
technology generates multiple
mammogram images
Hologic
DBT- digital breast tomosynthesis
Use dedicated software to do “Image quality of reconstructed image” per “Tomosynthesis” presentation in Vienna, ECR 2014,
Tomosynthesis (DBT)
Advanced digital mammography
technology generates multiple
mammogram images showing
slices of breast tissue
Analogy: x-ray is to CT as mammo is to tomosynthesis GE
Mammogram compared to Tomosynthesis
Confidential

5. Digital Mammography
Provide high quality images for early detection of breast cancer
QA Mammography Tools are required
Simulate radiographic attenuation characteristics of compressed breast tissues
Contain components that model breast disease & cancer
Support quality patient images
Tomosynthesis as compared to Mammography- similarities and differences
To pass the MQSA quality standards…must be visible with no obvious artifacts at an average glandular dose of less than 3 mGy
Gammex’s Mammo 156™ Phantom
Confidential

6. Full Field Digital Mammography (FFDM)
Benefits*
Increased detection of breast cancer
Reduced backscatter
First FFDM system FDA-approved and installed in 2000
Most Digital Mammography systems are capable of FFDM
*Diagnostic Radiology Imaging Physics Course , K. Kanal, Ph.D.
Confidential

7. Breast Tomosynthesis*
Currently in routine clinical use in 15% of systems globally
40-50% Rest of World
Estimate growth is % by 2025
3D, multiple images- Radiologists time is more than doubled
Compared to 2D mammography
Improves sensitivity & specificity
Cancers can be obscured by surrounding dense tissue
Current Tomosynthesis systems
Hologic- Genius 3D, FDA cleared
GE- SenoClaire 3D, FDA cleared
Siemens- FDA cleared
IMS Giotto- commercial use outside US
Planmed- research only
Philips- research only
Hologic major OEM in your region?
Tomosynthesis typical? %?
Confidential
*Lewin, J., M.D., Advanced Mammography Applications, AAPM Spring Meeting, March, 2014

8. QA and QC in Mammography*
QA Guidelines: requirements vary by region/country
International Atomic Energy Agency (IAEA)
European Commission/ EUREF
American College of Radiology (ACR)
Institute of Physics & Engineering Medicine (IPEM)
Royal Australian & New Zealand College of Radiologists (RANZCR)
Guidance Documents for QA & QC*
European Commission (EC) Protocol
Australasian College of Physical Scientists & Engineers in Medicine (ACPSEM)
Mammography Quality Standards Act (MQSA) in the US,1994
To pass the MQSA standards (ACR Mammography accreditation program):
Minimum of 4 fibers, 3 calcification groups & 3 masses
must be clearly visible & artifact-free
*Quality assurance and quality control in mammography, Insights Imaging 2013
Confidential

9. QA and QC in Mammography
QA methods are focused on dose and image quality performance
Acquisition, processing, display systems tested as part of the imaging chain
Dose assessment
Exposure assessment
Testing Automatic Exposure Control (AEC)
Low contrast detection
Spatial resolution
Signal to Noise
Use Gammex Phantoms,
Tools & Accessories
QA required: installation of new mammo system, weekly and annually
Confidential

10. QC: American College of Radiology*
ACR Accreditation Testing Instructions**
Position the phantom laterally on the receptor
Screen film, digital or FFDM processing instructions
Exposure instructions vary by make, model of system
Phantom image and dose**
Must submit image of an ACR-approved phantom
Mammography Quality Control Manual (Hendrick R., et al.)
Signal to noise (contrast to noise)
Phantom image quality evaluation
Score: Fibers, specs, masses
QA required weekly & annually
*Mammography Accreditation Program Requirements_ docx
**ACR Mammography Accreditation Program Testing Instructions (
Confidential

11. #1 phantom listed by the ACR
Mammo 156™ Phantom
Simulates radiographic attenuation characteristics
4.2cm slab (compressed breast tissue)
50% adipose tissue, 50% glandular
Provides physical standard baseline
Assures quality images & tests system sensitivity
Quickly detect objects from 0.16mm to 2.0mm
Identifies artifacts due to film and digital processing
Follows MQSA, ACR, IAEA & ACPSEM guidelines
Objects model breast disease & cancer
6 nylon fibers/ fibrils
5 simulated micro-calcification groups
5 low contrast simulated masses
Provides the physical standard baseline for assuring the quality of the images produced by your mammographic system.
PMMA, acrylic like substance can simulate how water attenuates at a fixed energy
We add our tissue mimicking wax to simulate fat and gland.
Cancer often manifests itself in very hard calcifications simulated by these objects
Simulates the x-ray attenuation of a 4.2 cm slab of compressed human breast composed of 50% adipose tissue and 50% glandular tissue.
Target objects in the phantom are of known size, shape, and density. These represent the different structures or malignancies found when imaging the breast.
Image quality and system sensitivity is evaluated using these targets and following ACR/MQSA guidelines in the US and ACPSEM in Australia and Asia, and EC in Europe.
Benefits
•Routine use of the Mammographic Accreditation Phantom 156 helps satisfy requirements of the ACR Accreditation program, the RANZCOR, etc. for mammography
•The Phantom is helpful in identifying artifacts due to grids, filters and film-processing (for film-screen systems) as well as those produced by digital mammography systems.
•Detect 16 different sizes of targets
•Detect targets down to 0.11 mm in size
•Detects tumor-like masses and micro-calcifications
#1 phantom listed by the ACR
since the start of the
MQSA Program in 1994
Confidential

12. Mammo 156 Stereo™ Phantom
Monitors mammography systems used for biopsy & localization
Simulates radiographic attenuation characteristics
4.2cm slab (compressed breast tissue)
50% adipose tissue, 50% glandular
Quickly detect objects from 0.20mm to 1.00mm
Follows MQSA, ACR, IAEA & ACPSEM guidelines
Designed to “hang” on the biopsy system detector
Objects model breast disease & cancer
4 nylon fibers simulate fibrous structures
4 simulated micro-calcification groups
Aluminum oxide specks
4 tumor-like masses
Assures quality images & tests system sensitivity
Used for monitoring digital mammo systems used for stereotactic biopsy and localization.
Benefits
•Digital and stereotactic systems
•Quickly detect a range of targets from 0.20 mm to 1.00 mm in size
•Economical
Features
•Compact size
•Wax insert contains 12 sets of test objects
•Approximates the size of a 4.2 cm compressed breast of 50% glandular and 50% adipose composition
•Wax insert contains
◦Simulated micro-calcifications of Aluminum oxide specks
◦Nylon fibers simulate fibrous structures
◦Lens-shaped masses simulate tumors
•Replaceable wax insert contains the targets
Confidential

13. FFDM (Full Field Digital Mammo) Phantom
Reduces scatter
Quickly detect objects 0.14mm to 1.0 mm
Objects mimic small structures important in early detection of breast cancer
6 nylon fibers simulate tumor-like fibrils
6 simulated micro-calcification groups
6 low contrast disks simulate masses
Cleared for use by FDA March 7
Alternative to the Mammo 156 (ACR phantom)
ACR to release the manual soon
Sales can begin when ACR releases phantom
Gammex’s Mammo FFDM™ Phantom
Finally cleared for use by FDA!
Confidential

14. Training Phantoms & Tools
Breast Compression Device
Screen film (SFM), digital and tomosynthesis require
breast compression
Lowers the radiation dose
Enhances image contrast
Improves visibility of pathologies
Stereotactic Breast Biopsy Phantom
Training tool for biopsy procedures
Multiple lesions, multiple uses, disposable
“Real feel” skin-like resistance to needle insertion
Compressible within a biopsy instrument
Ultrasound Breast Biopsy Phantom
Practice identification, aspiration & biopsy
Training tool, disposable
11 test objects imbedded
Confidential

15. Mammo Test Tools & Accessories
Beam alignment test tool (162a)
Collimator alignment test tool (161b)
Evaluate collimator light field and x-ray field congruence
Shine light on the collimator sheet of brass with the alignment test tool underneath and align the bbs that are in the top and bottom of the alignment tool
Ensure accurate x-ray beam alignment
Half value layer attenuator set (115a)
HVL is measured to calculate glandular dose
Confidential

16. Mammo QC Kits Developing new kits Mammographic QC Kit 182M, 182M-BR
Small clinics to teaching hospitals
kVp accuracy, AEC, timer
Half value layer, focal spot
Routine Mammographic QC Kit, 183
QA & demonstrations
Developing new kits:
1 with the 330 Meter
1 without the 330 Meter
1 with tools for AEC, HVL, etc.
Confidential

17. Competition: CIRS CIRS’ tomosynthesis phantom per TG245
Need a reproducible heterogeneous set
Not anatomically accurate enough
Need semi-automated software
Need slices with targets for multiple tests
ACR Accreditation
Phototimer Consistency
Tomosynthesis “Swirl”
Mammo Research Set
Confidential

18. Competition: PhantomLabs & Leeds
Tomophan
Voxmam
Performance testing
Non-tissue mimicking
Semi-automated software with ImageOwl
Performance testing
Tissue-mimicking
Confidential

19. Breast Tomosynthesis*
3D multiple images
Currently in routine clinical use- 15% of systems globally, >50% in greater Europe
Estimated to grow to % clinical use by 2025
Compared to 2D mammography
Improves sensitivity & specificity especially for dense tissue
Takes more time for the radiologist: 3-4 times longer to read images
Tomosynthesis is to Digital Mammography as CT is to MR
Multiple slices digitally combined
*Lewin, J., M.D., Advanced Mammography Applications, AAPM Spring Meeting, March, 2014
Confidential

20. DBT Phantom Development
What and who are driving our development?
TG 245 Tomosynthesis phantom development NEEDS:
Phantom that is more specific than existing CIRS
Test stability of the system & quantify aspects of the DBT image quality
Reproducible non-heterogeneous TMM phantoms
Adipose/glandular
European DBT QC Protocol
IEC 62B/ MT31 Committee- Steve Glick, Wei Zhao
Who we are working with
Hologic- Nikos Gkanatsos
Siemens- Thomas Mertelmeier and Sebasitan Vogt
GE- Razvan Iordache
Sara Vecchio-IMS, Italy
Srini Vedantham, University of MA
Mitch Goodsitt, University of Michigan
Confidential

21. DBT Phantom Development
Our new design can test
Energy response
Spatial resolution
Low contrast resolution
Uniformity
Geometric distortion
Line Spread Function (LSF)
Edge test method
DBT Materials
Material composition
ICRU44, Hammerstein
Breast, Adipose, Glandular Tissue
Parenchymal patterns
Iodine and other contrast agents
Gather customer input, mimic human tissue, combine with our expertise and technology
Confidential

22. DBT Phantom Development— Use the appropriate targets
ACR 464 Accreditation Phantom Targets
FFDM
Phantom Targets
Combination of targets
ACR 464
CT number accuracy
Bone, Air, Acrylic, Water, PE
FFDM
Smallest masses, fibrils & calcifications
Additional targets as required
Bone
955 HU
Polyethylene
-95 HU
Water
0 HU
Acrylic
120 HU
Air
-1000 HU
Confidential

23. DBT Phantom Development Ensure the highest quality patient images
A platform of tomosynthesis phantoms & analysis software
Iterating material compositions for adipose, glandular and breast
Prototyping DBT phantom shape, size and thickness
Developing analysis software for the physicist and technologist
Slices of varying composition with various targets
Confidential

24. DBT Phantom Development Next Steps
New phantom sets to be made, based on feedback from TG 245 and RSNA meetings and imaging of our prototypes
Imaging of new phantoms at multiple sites
Develop software specifications
Goals:
Meet needs of TG 245 and OEMs
Release phantom sets this year
Complete and verify software specifications by end of the year
CEDM uses iodinated contrast in conjunction with a dual energy image acquisition to produce contrast-enhanced images. For women with dense breasts and gene mutation
CESM Contrast Enhanced Spectral Mammography uses X-ray contrast agent and a dual-energy acquisition technique: contrast-enhanced areas of blood flow through angiography of the breast using an IV iodine contrast agent. The contrast helps visualize localized increased blood flow pointing to areas of potentially cancerous lesions. Compares to CE MRI, less costly and more accessible
TG245, Sara V. is on this TG
TG223, Mitch G. on this TG
Confidential

25. Gammex: Global Leader FIRST in the world
> 11,400 Mammo 156 Phantoms sold
Most referenced mammography phantom in publications & other QC programs: “Gammex 156 or equivalent”
Best QC in our manufacturing process: Zero failures in the field since 2009
Confidential

26. Questions?
Confidential

27. Thank you
Confidential

28. Appendix
Confidential

29. Mammo Test Tools & Accessories
High contrast resolution test tool (141), mesh
For fluoroscopy, “moving x-rays”
Interventional radiology in cath labs
Low contrast resolution test tool - (151)
For fluoroscopy and smaller percentage for radiography
Measuring the radiation exposure, need to keep radiation level down to 10R per minute, max.
Confidential

30. Mammo Test Tools & Accessories
Portable densitometer with charger
330 digital kv meter
High purity aluminum half value layer set (6)
Test patterns
Confidential

31. Material Composition Hammerstein versus ICRU44 for Breast
What is the consensus on elemental composition?
What is the recommendation and/or who decides (OEMs, IEC 62B/MT31, AAPM, Clinical Opinion Leaders)?
Confidential