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EARL at a Glance: History, Projects, Visions 30.10.2012...
Transcript of EARL at a Glance: History, Projects, Visions 30.10.2012...
EARL at a Glance: History, Projects, Visions
30.10.2012 EANM‘12
� EANM founded the EANM Research Ltd in 2006
(Nominal capital of € 35.000)
� EANM is 100% shareholder
� Rationale: Liability
� CEOs
A. Bauer K. Tatsch
History of EARL
EARL at a Glance
EARL was created to unleash the power of molecular imaging and further:� To improve nuclear medicine and its practice within the European Union
� To provide a basis for discussion and the exchange of cutting edge ideas
� To act as a contact point for researchers as well as for clinicians and business leaders
� To provide a platform for the efficient pursuit of scientific initiatives
� To facilitate multicentric research projects
� To enhance the comparability of data acquired by molecular imaging
� To boost molecular imaging so that it becomes a standard diagnostic modality in future clinical medicine and research
� To position nuclear medicine within the EU research agenda
Organisational Structure
EARL
Scientific Advisory Board
ENC-DAT EARL FDG PET/CT Accreditation
WG to review FDG PET guidelines
EPIBTaskforce
EU grants
PEDDOSE.NET
EIBIR Project
MEDRAPET
ESR Project
CEO
K. Tatsch
CEO
A. Bauer
� CEOs report to EANM Executive Committee
� Committees (Networks of Excellence, NoEs)
� ENC-DAT study
2006 – 2010 EARL conducted its first research project:
“European database of [123I] FP-CIT (DaTSCAN) SPECT
scans of healthy controls (ENC-DAT)”.
• 13 centers in 10 European countries
• Multicenter cross-calibration
• Standardized evaluation by core labs
EARL Project
EARL Project
�Rationale ENC-DAT study:
�Overcome limitations
due to:
Lack of standardization• camera performance • acquisition parameters• processing• quantification
Lack of reference data baseof healthy controls• age corrected• gender values
DaTSCAN SPECT:
In clinical practice and clinical trials the quality spectrum of scansranges from excellent to nondiagnostic
� ENC-DAT study part 1: Quality control of imaging device
Gamma camera-certification (1 expert physicist)Initial:
I-123 intrinsic uniformitySystem uniformity with Co-57System sensitivity with I-123Quantitative SPECT resolution with I-123Qualitative resolution planar CORAntropomorphic 3D striatal-phantom
Periodically:System uniformity with Co-57COR
EARL Project
� ENC-DAT study part 2: Phantom measurements
Cross calibration between camera systems
EARL Project
TRUE = 1.0139*measured
R2 = 0.9844
-1
0
1
2
3
4
5
6
7
8
9
10
-1 0 1 2 3 4 5 6 7 8 9 10
Measured SBR (ACSC)
Tru
e S
BR
� ENC-DAT
study:
Equipment
EARL Project
Centre Scanner Collimator
Amsterdam Strickmann N/A
Siemens E-Cam LEHR-PAR
Ankara GE Infinia LEHR-PAR
Copenhagen Philips IRIX LEGP-PAR
Genoa GE Millennium VG LEHR-PAR
Leipzig Uni DSI Ceraspect N/A
Siemens Symbia LEHR-PAR
Leuven Siemens E-Cam LEHR-PAR
Philips IRIX LEUHR-FAN
London GE Infinia Hawkeye LEHR-PAR
Munich Picker Prism3000 LEHR-FAN
Siemens Symbia LEHR-PAR
Nice Picker Prism3000 LEUHR-FAN
Stockholm Trionix TRIAD LEUHR-PAR
Yvoir Trionix TRIAD LEUHR-PAR
Philips IRIX FANB-Asymmetrical
Milan Philips IRIX LEUHR-FAN
Picker Prism LEHR-PAR
Southampton GE Infinia Hawkeye LEHR-PAR
Mediso LEHR-PAR
Vienna GE Millenium LEHR-PAR
Philips IRIX Precision LEHR-PAR
� ENC-DAT study: Recruitment
EARL Project
Age
20-30
30-40
40-50
50-60
60-70
70-80
80-90
Total
Age
yrs male female male female male female male female male female male female male female male female
20-30 1 2 2 3 1 1 1 1 1 1 1 1 1 1
30-40 2 1 2 1 1 1 1 1 1 1 1 1 1
40-50 1 1 1 1 1 1 1 1 1 1 1 1 1 1
50-60 1 1 2 2 1 1 1 1 2 1 1 1 1
60-70 4 3 3 1 1 2 2 2 3 1 1 1 1
70-80 1 1 1 1 2 1 1 2 0 1 1 1 2
80-90 1 0 0 1 1
5 5 5 5 10 6 7 7 7 7 9 7 7 7 5 7
Total 16
Munich Leuven Yvoir Nice
1410 14
Amsterdam
10 16
Ankara GenoaCopenh. R.
1214
Age
20-30
30-40
40-50
50-60
60-70
70-80
80-90
Total
male female male female male female male female male female male female total
1 1 1 1 9 13 22
1 1 1 1 1 1 1 1 14 9 23
2 2 1 1 1 1 13 9 22
1 2 1 1 9 12 21
2 1 3 4 1 1 20 17 37
2 2 1 0 2 1 12 11 23
1 3 1 4
8 7 5 5 7 7 3 0 2 2 80 72
152
Southampton
315
Stockholm
14
London
10
Vienna TotalLeipzig
4
� ENC-DAT study part 3: Healthy subjects
EARL Project
�No history of parkinsonism in first-degree relatives�No medication known to affect DAT binding�UPDRS score: < 60 yrs = 0; ≥ 60 yrs ≤ 5�SCL-90-R score < 63�BDI score ≤ 9�MMSE ≥ 28�Negative urine based screening for drug abuse (10 drugs)�Edinburgh Handedness Test�Copenhagen Smoking Questionnaire�MRI: < 60 yrs ARWMC score 0; > 60 yrs score ≤ 2
� ENC-DAT study part 3: Healthy subjects
EARL Project
y = -0.0566x + 11.897
R2 = 0.4213
y = -0.0531x + 11.471
R2 = 0.3832
2
4
6
8
10
12
14
16
10 20 30 40 50 60 70 80 90
age (years)
SB
R (A
CS
C)
F
My = -0.0547x + 11.668
R2 = 0.3978
2
4
6
8
10
12
14
16
10 20 30 40 50 60 70 80 90
age (years)
SB
R (A
CSC
k=adj)
ALL SBR = -0.0547 * age + 11.668 R2 = 0.398SBR = -0.0566 * age + 11.897 R2 = 0.421
SBR = -0.0531 * age + 11.471 R2 = 0.383
� ENC-DAT study part 3:
Healthy subjects
• World’s largest normal data base of FP-CIT scans
• 152 subjects, 20 to 90 yrs
• Balanced gender
• Intensive neurological/neuropsychiatric evaluations
• MRI scans
• Highly significant relationship between DAT binding and age (decline per decade: 4.6%)
FP-CIT SPECT scans of healthy subjects
EARL Project
� ENC-DAT study outcome
• The normal database established by this project is a valuable
benchmark for Nuclear Medicine centres performing
neuroimaging studies.
• Database was sold to GEHC and HERMES
(further companies have expressed interest).
• Study data are available (online) for scientific projects of
participating sites (n > 10).
• Publications can be found on http://earl.eanm.org
EARL Project
EARL Project
1.Proposal for the standardisation of multi-centre trials in nuclear medicine imaging: prerequisites for a European 123I-FP-CIT SPECT database. Dickson JC, Tossici-Bolt L, Sera T, de Nijs R, Booij J, Bagnara MC, Seese A, Koulibaly PM, Akdemir UO, Jonsson C, Koole M, Raith M, Lonsdale MN, George J, Zito F, Tatsch K. Eur J Nucl Med Mol Imaging. 2012 Jan;39(1):188-97.
2.Calibration of gamma camera systems for a multicentre European ¹²³I-FP-CIT SPECT normal database. Tossici-Bolt L, Dickson JC, Sera T, de Nijs R, Bagnara MC, Jonsson C, Scheepers E, Zito F, Seese A, Koulibaly PM, Kapucu OL, Koole M, Raith M, George J, Lonsdale MN, Münzing W, Tatsch K, Varrone A. Eur J Nucl Med Mol Imaging. 2011 Aug;38(8):1529-40.
3.European multicentre database of healthy controls for [¹²³I]FP-CIT SPECT (ENC-DAT): age-related effects, gender differences and evaluation of different methods of analysis. Varrone A, Dickson J, Tossici-Bolt L, Sera T, Asenbaum S, Booij J, Kapucu O, Kluge A, Knudsen GM, Koulibaly PM, Nobili F, Pagani M, Sabri O, Vander Borght T, Van Laere K, Tatsch K. Eur J Nucl Med Mol Imaging. EPUB, DOI: 10.1007/s00259-012-2276-8.
ENC-DAT Publications: Group
EARL Project
1. The impact of reconstruction method on the quantification of DaTSCAN images. Dickson JC, Tossici-Bolt L, Sera T, Erlandsson K, Varrone A, Tatsch K, Hutton BF. Eur J Nucl Med Mol Imaging. 2010;37:23-35
2. No association between striatal dopamine transporter binding and body mass index: A multi-center European study in healthy volunteers. van de Giessen E, Hesse S, Caan MW, Zientek F, Dickson JC, Tossici-Bolt L, Sera T, Asenbaum S, Guignard R, Akdemir UO, Knudsen GM, Nobili F, Pagani M, Vander Borght T, Van Laere K, Varrone A, Tatsch K, Booij J, Sabri O. Neuroimage. 2012 Sep 13;64C:61-67.
3. Automatic semi-quantification of [123I] FP-CIT SPECT scans in healthy volunteers using BASGAN -version 2. Results from the ENC-DAT database. Nobili FN,. Shoustari MN, De Carli F, Asenbaum S, Booij J, Darcourt J, Ell P, Kapucu Ö, Kemp P, Varer C, Morbelli S, Pagani M, Sabri O, Tatsch K, Tossici-Bolt L, Sera T, Vander Borght T, Van Laere K, Varrone A. Eur J Nucl Med Mol Imaging. Accepted, in Press.
4. Value of semi-quantitative analysis for clinical reporting of [123I]FP-CIT SPECT studies. Söderlund TA, Dickson JC, Prvulovich E, Ben-Haim S, Kemp P, Booij J, Nobili F, Thomsen G, Sabri O, Koulibaly PM, Akdemir OU, Pagani M, van Laere K, Asenbaum-Nan S, George J, Sera T, Tatsch K, Bomanji J. JNMMI (accepted with minor revision).
5. Association of serotonin transporter availability and body mass index in healthy Europeans. Hesse S, van de Giessen E, Zientek F, Petroff D, Winter K, Dickson JC, Tossici-Bolt L, Sera T, Asenbaum S, Darcourt J, Akdemir UO, Knudsen GM, Nobili F, Pagani M, Vanderborght T, Van Laere K, Varrone A, Tatsch K, Sabri O, Booij J. Obesity; in review
ENC-DAT Publications: Center-Based Projects
EARL Project
GE-HC: Quantification based on
ENCDAT: DaTQUANT
• DaTSCAN template of healthy controlsfrom ENCDAT
• MNI space
• VOI map (S,C,P,AP,PP)
• Co-registration
• SBR
• P/C
• Asymmetry
EARL Project
Hermes: Quantification
with ENC-DAT BRASS
• DaTSCAN template of healthy controlsfrom ENCDAT
• MNI space
• VOI map
• Co-registration
• SBR
• P/C, PP/AP/C
• Pixelwise comp.
• Age corrected reference values
• Camera specific
� „Calibration of cameras“
EARL offers a service of „calibration of gamma cameras
for ENC-DAT”. An expert physicist comes to calibrate the
equipment in the individual department in the same way as
done for the ENC-DAT project. Thus, the departments’
measurements can easily be compared with the normal
database of the DaTSCAN project.
EARL Service
� Accreditation program
• Quality standard: FDG-PET and PET/CT – EANM procedure
guidelines for tumour PET imaging (version 1.0)
• Online questionnaire
• Quarterly calibration quality control (QC) and annual image
quality QC
• Europe-wide
PET/CT systems are operated quantitatively and have a similar
performance in a multicenter setting.
EARL FDG-PET/CT Accreditation
� EARL: accreditation of imaging sites for EORTC Trial
• EORTC Imaging Group (S. Stroobants)
• Accreditation of 11 sites in D, NL, B, F
• EORTC will only allow accredited imaging centers to
participate in their trials
• MoU between EANM/EORTC:
a) incorporating PET/CT in clinical trials from the very
beginning
b) quality standard
EARL FDG-PET/CT Accreditation
� EARL: accreditation of imaging sites in NM
• First step: EARL asked 60 top imaging centers in Europe to
accredit themselves (EARL charges € 1000.- service fee)
• Second phase: EARL aims at asking all NM departments in
Europe to accredit themselves
• Benefit for the centers: they can join oncological research
projects and sites are published on the EARL/EANM website
as PET/CT accredited sites; certificate; quality label for
machine
EARL FDG-PET/CT Accreditation
�EPIB (European initiative for PET as Imaging Biomarker)
• Inter-Committee working group was set up in 2010
(Representatives of the Oncology, Translational Molecular
Imaging, Radiopharmacy and Drug Development Committees)
• To raise awareness and enforce acceptance and legislation of PET
as Imaging Biomarker
• EU is just beginning to consider the topic „biomarkers“
EARL Project
� Taskforce-EU Grants
• Created in June 2011
• Aim: to raise awareness within the nuclear medicine community of
the necessity of competing for EU research grants as well as
conducting multicentre studies.
• Main objectives:
− To boost the role of molecular imaging in personalised medicine
− To make the European Union (EU) aware of research topics in
nuclear medicine which will be pivotal in the future
− To follow open calls from the EU and the development of recent
grants in order to develop opportunities for nuclear medicine
EARL Project
� EANM is shareholder of EIBIR
(European Institute for Biomedical Imaging Research)
K. Tatsch is official representative of EANM at EIBIR
• PEDDOSE.NET (2010)
„Dosimetry and Health Effects of Diagnostic Applications of
Radiopharmaceuticals with particular emphasis on the use in
children and adolescents.“
EANM - EIBIR
� PEDDOSE.NET (2010) Objectives:
• Summary and evaluation of current knowledge on the impact onpatients' health of small and non- or little-repetitive doses (amounts) ofradioactive, biological and/or chemical substances, as currently usedin diagnostic imaging procedures
• Development of recommendations and guidelines to drive scientificand technologic innovation to improve patient healthcare in med. imaging
• Identification, if clinical studies are needed, and correspondingdetailing of the studies
• Involvement of people in legislative approval of these agents forhuman use
Aim: Development of recommendations and guidelines
EANM - EIBIR
� MEDRAPET (2010)
„Study on the Implementation of the Medical Exposure Directives
Requirements on Radiation Protection Training of Medical
Professionals in the European Union.“
• The results of the 27-months project will form the basis for the revision of the
Radiation Protection 116 Guidelines on Education and Training in Radiation
Protection for Medical Exposures.
• Aim is to provide an improved implementation of the Medical Exposure
Directive provisions related to radiation protection education and training of
medical professionals in the EU Member States.
EANM - EIBIR
� Complementing / implementing EANM vision of “going clinical”
� Extend FDG PET/CT accreditation to NM in whole of Europe
� Raise awareness with “big pharma” / CROs of the importance
of standardization of imaging
� Relevance of multicentre trials for innovative
radiopharmaceuticals
EARL Visions
� What can EARL do for you:
� provide an extensive network of excellent professionals
in the field of nuclear medicine.
� facilitate your clinical (multicentric) study. EARL works
closely together with the principal investigator (PI) as well
as the contract research organization (CRO).
� provide a platform for scientific initiatives.
EARL4you
� What can EARL do your you:
� open to cutting edge ideas – requests for academic/
commercial research projects can be directed to EARL.
� ready to accept project proposals from nuclear medicine
stakeholders, preferentially in the following priority fields:
Cardiology, Drug & Radiopharmaceutical Development,
Neurology/Psychiatry, Oncology, Paediatrics, and
Radionuclide Therapy.
EARL4you
� Create a Win-Win situation by financial support of EARL:
� Associate your Company’s name with the future of molecular imaging
now, and harvest the fruits of your commitment soon, by:
� Increasing the use of molecular imaging in clinical medicine
� Accelerating the development of new radiopharmaceuticals
� Stimulating multicentre drug development and biomedical research
� Ultimately increasing your sales in nuclear medicine
� For discussion of individual models of support or further information
please contact EARL.
EARL – Share our Vision