The Radiological Society of
North America
Founded in 1915
Imaging Societies
as
Stakeholders in Quantitative
Imaging and Biomarkers
Quantitative Imaging &
Imaging Biomarkers:
-Complex Challenges
-Extraordinary Opportunity
-Multiple Stakeholders
Patients
Clinicians
Clinical researchers
Imaging professionals
Imaging societies
Imaging equipment manufacturers
Pharmaceutical, biologics manufacturers
Software developers
NIH– Roadmap; Biomarkers Consortium
FDA– Critical Path Initiative
CMS & healthcare insurers
Healthcare purchasers
.org
Why?
Because…
…of what the future will demand of us
…there is much we can do to advance the field
.org
Who are the imaging organizations and
what has all this to do with them (us)?
50 imaging organizations
Diverse interests
Academy of Radiology Research
AMA Section Council on Radiology
American Association for Women Radiologists
American Alliance of Academic Chief Residents in Radiology
American Association of Physicists in Medicine
American Board of Nuclear Medicine
American Board of Radiology
American Brachytherapy Society
American College of Medical Physics
American College of Nuclear Medicine
American College of Nuclear Physicians
American College of Radiology
American College of Radiology Council
American College of Radiology Private Practice
American College of Radiology Residents
American Institute of Ultrasound in Medicine
American Osteopathic College of Radiology
American Radium Society
American Roentgen Ray Society
American Society for Therapeutic Radiology and Oncology
American Society of Clinic Radiologists
American Society of Emergency Radiology
American Society of Head and Neck Radiology
American Society of Interventional & Therapeutic Neuroradiology
American Society of Neuroradiology
Association of Program Directors in Radiology
Association of Residents in Radiation Oncology
Association of University Radiologists
Association of VA Radiologists
Canadian Association of Radiologists
Council on Cardiovascular Radiology and Intervention of the AHA
Fleischner Society
International Skeletal Society
International Society for Magnetic Resonance in Medicine
National Medical Association, Section on Radiology
North American Society for Cardiac Imaging
Radiological Society of North America
Radiological Society of North America R & E Foundation
Society for Computer Applications in Radiology
Society for Pediatric Radiology
Society for the Advancement of Women's Imaging
Society of Breast Imaging
Society of Computed Body Tomography and Magnetic Resonance
Society of Gastrointestinal Radiologists
Society of Interventional Radiology
Society of Nuclear Medicine
Society of Radiologists in Ultrasound
Society of Skeletal Radiology
Society of Thoracic Radiology
Society of Uroradiology
Imaging Organizations
All 50 share a common interest:
The use of imaging in clinical medicine
And a common objective:
Safe, high-quality, personalized care
Minimum effort: respond to change
Ideal: collaborate and direct change
Powerful Forces of
Change
Data deluge, workflow issues
Genomics, personalized medicine
Healthcare quality & safety movement
Maintenance of Certification
Pay-for-performance
PACS, teleradiology, imaging technology,
market forces
commoditization
Snapshot: Diagnostic Radiology
Training & Practice
Images courtesy of Janet Strife, M.D.
187 N. American training programs
Apprenticeship-like environments
Qualitative interpretation
Pattern recognition
Few quantitative methods
Not imaging-science intensive
Lack of research culture
Few qualified trained clinical trialists
Change
Deming – “You don’t have to [change].
Survival is not compulsory.”
Darwin – “It’s not the strongest of the
species that survive, nor the most
intelligent, but the one most responsive to
change.”
Data Explosion
1996
1998
2001
2005
HiSpeed Cti
LightSpeed QX/I
LightSpeed Ultra
LightSpeedVCT
10mm
2.5mm
1.25mm
.625mm
30 slices
120 slices
240 slices
480 slices
“It is like trying to find a smaller and smaller needle
in a larger and larger haystack.”
Slide courtesy of Wesley Turner, Ph.D., formerly of GE Global Research, currently in Research at Kitware, Inc.
Data Explosion
And this is just the anatomic imaging data of
contemporary imaging practice.
Let’s not forget the functional and molecular
imaging data that will soon underpin both
clinical trials and practice.
Data Explosion = Opportunity for
Quantitative Approaches…
in Detection, Dx,
Response to Tx, IGI,
but…
…full range of
validated software
tools will be needed
Personalized Medicine
Exploiting the Human Genome in Health & Disease
Personalized Medicine
Exploiting the Human Genome in Health & Disease
Molecular signatures of disease
Targeted Tx; Measurement of response
Detection; Diagnosis; Disease quantification;
Localization; Prediction of response to Tx
Molecular imaging to play a key role
Quantitation essential to clinical trials, practice
To add value, clinical imagers must embrace and
master quantitative methods
Targeted Drugs to Treat Cancer
CANCER
DRUG
ACTION
Colorectal cancer
Bevacizumab (Avastin)
Cetuximab (Erbitux)
Irinotecan (Campto)
Capecitabine (Xeloda)
Oxaliplatin (Eloxatin)
Angiogenesis inhibitor
EGFR inhibitor
Topoisomerase inhibitor
DNA/RNA synthesis inhibitor
DNA/RNA synthesis inhibitor
Multiple Myeloma
CML, GIST
Bortezomib (Velcade)
Proteasome inhibitor
Imatinib mesylate
(Gleevec, Glivec)
Tyrosine kinase inhibitor
Lung cancer
Geftinib (Iressa)
Erlotinib (Tarceva)
EGFR tyrosine kinase inhibitor
EGFR tyrosine kinase inhibitor
Breast cancer
Exemestane (Aromasin)
Letrozole (Femara)
Anastrozole (Arimidex)
Tamoxifen
Fulvestrant (Faslodex)
Trastuzumab (Herceptin)
Aromatase inhibitor
Aromatase inhibitor
Aromatase inhibitor
Estrogen receptor antagonist
Estrogen receptor antagonist
Anti-Her2/neu monoclonal Ab
FES (18F-Estradiol) Uptake on PET
Predicts Response of Breast CA to
Hormonal Therapy
Example 1
• Recurrent
sternal lesion
Pre-Rx
Post-Rx
Excellent
response
after 6 wks
Letrozole
• ER+ primary
• Recurrent Dz
strongly FES+
Example 2
FES
• Newly Dx’d
breast cancer
• ER+ primary
• FES-neg
bone mets
Univ of Washington
FDG
FDG
No response
to several
different
hormonal
Rx’s
Quon, A. et al. J Clin Oncol; 23:1664-1673 2005
DCE-MRI predicts response of
Colorectal CA to Vatalanib
DCE MRI: Patient with Colorectal CA Treated with PTK 787 (Vatalanib)1
Baseline
Day 2
Ki dropped from 100% baseline to: 31% on day 2
34% at end cycle 1
Ki: bi-directional transfer constant
15% at end cycle 2
Thomas et al. EORTC-NCI-AACR 2002.
1VEGF
Receptor Tyrosine Kinase Inhibitor
How New Imaging
Technologies Get Introduced
Old paradigm: add newly developed technology
to traditional imaging practice
Currently:
-Molecular & functional measures assuming
greater importance
-Most radiology departments configured in
anatomic/modality sections
-Few radiologists involved in imaging science
or technology development
For imaging professonals to add value to
personalized medicine, we will need:
Massive culture shift in training and practice
To embrace quantitative methods
Robust offering of validated software tools
Standardized lexicon/ontology such as RadLex
Structured reporting (will facilitate, practice, research,
QI, coding/billing)
To participate in clinical trials
Standardize protocols
Interoperable imaging hardware across sites,
practices, clinical trials
How will imaging specialists add
value to personalized medicine?
Pre-Tx sorting of responders & non-responders
Rapid assessment of response to initiated Tx
Verifying Tx targeting in “theragnostics”
Measuring response to Tx
Rendering prognostic information
Imaging clinical trialists will provide the quantitative
data that will underpin regulatory approval of
new biologics and pharmacotherapeutics
Apply quantitative methods in IGI
Quality & Safety Movement
in U.S. Healthcare
INSTITUTE OF
MEDICINE
2001: Crossing the Quality Chasm
Today’s U.S. Healthcare System
“Healthcare system fails to translate
knowledge into practice.”
“A highly fragmented delivery system
results in poorly designed care and
duplication of services.”
Health Care Spending as a Share of U.S.
Economic Output Rising Steadily
Overall, About Half of
Recommended Care Is Delivered
About 50-54% of
care that
Americans
receive…
Care that
meets
quality
standards
…is care that is
actually
recommended
McGlynn EA, Asch SM, Adams J, et al. The
quality of health care delivered to adults in the
United States. N Engl J Med 2003;348:2635-45.
INSTITUTE OF
MEDICINE
Calls for fundamental change
in aims, with delivery of
healthcare that is:
2001
Safe
Effective
Patient
centered
Timely
Efficient
Equitable
Assuming Responsibility for Patient
Safety & Healthcare Quality
Stakeholders Taking Action
JCAHO: National Patient Safety Goals
NCQA: Accred., Certification, Physician
Recognition
NQF: List of 30 safe practices
IOM: Top 20 national healthcare priorities
IHI: 100,000 Lives Campaign (now 5 million)
National Patient Safety Foundation (& other)
State medical boards: sentinel event reporting
Payors (including CMS): P4P, PQRI
Assuming Responsibility for Patient
Safety & Healthcare Quality
Radiology Leadership Groups Taking Action
Specialty & subspecialty society quality committees
Journal editors: journal sections, articles on quality
Quality programs at society meetings
Sun Valley Group: Radiology Quality Summit
International Radiology Quality Network (IRQN)
Member Boards of ABMS: MOC Programs: Component 4, we
strive to improve what we do, not just what we know
Technological solutions in
quality improvement
Computerized Physician Order Entry
Scheduling, tracking, workflow software
Objective quantitative interpretation with
use of validated software
Structured reporting, with standardized
Lexicon/ontology
Software-enabled measurement of
report timeliness, accuracy
The Radiological Society
of North America
Founded in 1915
Standards are important
Courtesy of R. Gilbert Jost, M.D.
Leader in Technology &
Standards for Imaging &
Healthcare
DICOM
®
IHE
Integrating the Healthcare Enterprise
MIRC
Medical Imaging Resource Center-software toolkit
RadLex®
Ontology for Uniform Indexing & Retrieving Image Info
-Imaging research databases
-Educational materials
-Clinical imaging reports
.org
Leader in Technology &
Standards for Imaging &
Healthcare
Open source software toolkit
Acquires image data from modality or
PACS
De-identifies
http / https transfers (encrypted)
Organizes transferred data
Has query function
Now in use in clinical trials*, caBIG
*ACCORD, WHIMS, RIDER, CAMP, Other
.org
Integrating the
Healthcare Enterprise
An initiative to achieve efficient exchange of healthcare
information through implementation of standards
Supported widely by healthcare IT and imaging
industries
Industry reps work with healthcare professionals
Create Integration Profiles, guidelines for implementing
interoperability standards
Participating vendors implement, test and demonstrate
products incorporating these solutions
Major component of EHR initiative in U.S.
Roles for the RSNA in Collaboration
with other Imaging Organizations
1.
Convener of imaging biomarker stakeholders
2.
Forum for scientific presentations on latest science in
imaging biomarkers—Annual Meeting
3.
Coordinate efforts to reduce measurement uncertainty
4.
Sponsor, organize, conduct imaging biomarker
methodology workshops
5.
Publish proceedings
6.
Dedicated annual meeting (“Toward Quantitative
Imaging)?
7.
As with IHE, facilitate development of consensus stds
among industry stakeholders (device, PhRMA, CROs)
Roles for the RSNA in Collaboration
with other Imaging Organizations
8.
9.
Play larger, central role in several related activities:
-IRATs
-Imaging informatics (eg. caBIG)
-UPICTs, similar efforts
-Archive development
Internationalize the effort
10. In conjunction with NIH: organize, train, qualify clinical
trialists, imaging scientists
11. Provide infrastructure, tools to facilitate clinical trials
(MIRC, RadLex, IHE’s TCE Profile, other)
12. Establish network or cooperative group of qualified
imaging trialists who utilize common standards
13. Participate in the FNIH Biomarkers Consortium