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