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TRANSCRIPT
Tying the Pieces Together
Imaging Innovations
Dilemma
• Suppose we create a new, innovative modality
Dilemma
• For this new modality, assume that: – No standards exist for communicating outputs – No guidance exists for how to display the results
Dilemma
• The new modality must be put into clinical practice to prove its efficacy – Vendors won’t implement
storage and display until standards exist
– Standard development begins when there is demand
– Demand forms once the modality is proven clinically useful
Implementation
Standards
Clinical Efficacy
Dilemma
• To allow the innovative modality to be tested in clinical practice … – Workarounds may be devised to make clinical
testing practical: • Overloading old standards for storage / interchange • Developing proprietary display devices
FFDM ABUS Tomo
2D CAD 3D CAD Density
How We Got To This Meeting
Breast Tomosynthesis
Before a Standard
• Stored tomosynthesis slices within Secondary Capture Image (SC) objects so that (most) PACS could store them1
• Used proprietary compression (make images
small so PACS admins wouldn’t object)
1. Other tomosynthesis vendors chose to store slices as CT Image objects
Preparing for Standards
• In some cases we sequestered the SC objects for later conversion to standard objects
• Offered to convert the SC objects once the PACS and PACS display adopted the standard
And Then …
• We did what we had to do … – We figured out some workarounds – We got astounding clinical results that
demonstrated clinical efficacy of tomosynthesis – Began the standardization effort
An Aside
• During the standardization effort, did anyone ever ask how big a resulting DICOM Breast Tomosynthesis Image object would be?
How Are We (Collectively) Doing?
Breast Tomosynthesis
DICOM Standards
• Breast Tomosynthesis Image (BTO) in 2008 • Breast Projection X-Ray Image (in process) • Breast Tomosynthesis CAD (no FDA approval)
IHE Profiles
• IHE Radiology Mammography Image Profile – A good start for tomo – Is an extension for tomosynthesis necessary?
Standards Adoption After 5 Years*
0 1 2 3 4 5 6 7 8 9
10
# of
Site
s
Store Display
* BTO Storage and Display users from Hologic installed base
Standards Adoption After 5 Years*
• Worldwide BTO Use: – 13 vendors storing – 8 vendors displaying – Many more “working on it” – 30 sites are using BTO (< 5%)
* BTO Storage and Display users from Hologic installed base
Barriers to Standards Adoption
• BTO file sizes are large (~1.6 GB/study)
• Cost to upgrade PACS for tomo with BTO? – Big university hospital in the Midwest – $1.3 MM for upgrade to store BTO (incl. storage) – Site continues with SC objects sequestered
Predictions for the Future
• Tomosynthesis is inevitable because it’s better – Sites and their PACS need to adapt
• Unless something changes in our collective
approach, the next modality innovation will go the same way – And the next innovation is already FDA approved
and commercially available … C-View
Why?
• No vendors will implement storage and display until standards exist
• No standards work will begin until there is demand from users
• There will be no demand before the technology is shown to be clinically useful
Nonetheless