1. Mid-Term Review – Workpackage 3 « New methods of assessment of ReDVA using imaging techniques » E. Lancelot – 03/06/2015

2. Mid-Term Review – Workpackage 3
Part 1: presentation of the research team
Part 2: individual report

3. WP2 Milestones, Tasks and Deliverables
M2.1 Completion of clinical data mining and analysis  09/2014
T2.3 Surveillance of ReDVA (US, venography, MRI)
=> Imaging techniques for VA surveillance
T2.4 Criteria for intervention (loss of patency…)
=> Imaging techniques for pre-intervention VA assessment
T2.6 ReDVA patency changes over two years
=> Imaging techniques for post-intervention VA assessment
D2.1 Report on data collection and archiving standards  03/2015
=> Identification of newer methods (MRI) for VA assessment

4. WP3 Milestones, Tasks and Deliverables
T3.1 Standardisation of US technique
D3.1 Report on standardisation of US technique  03/2015
D3.2 Evidence of validation of MRI technique  09/2015
T3.2 Technique evaluation on an observational patient cohort
D3.3 Report on observational studies using conventional and new imaging techniques for VA assessment  03/2018

5. WP2&3 Research Team
VA surveillance
Pre-intervention VA assessment
Post-intervention VA assessment
Identification of newer methods
Standardization of US
Validation of MRI
Observational studies
D. Cassidy + Z. Khawaja
+ R. Jones + S. Bell
DC + ZK + RJ + R. Ross
DC + ZK + RJ + L. Browne + S. Broderick + E. Kokkalis + S. Gandy + JS. Raynaud

6. Pre-intervention VA assessment Post-intervention VA assessment
WP2&3 Research Team
VA surveillance
Pre-intervention VA assessment
Post-intervention VA assessment
Identification of newer methods
Standardization of US
Validation of MRI
Observational studies
 03/2015
D. Cassidy + Z. Khawaja
+ R. Jones + S. Bell
 03/2015
DC + ZK + RJ + R. Ross
 09/2015
DC + ZK+ RJ + L. Browne + S. Broderick + E. Kokkalis + S. Gandy + JS. Raynaud

7. Roles of the Team Members
D. Cassidy
Analysis of the place of imaging in international VA guidelines
Literature screening for the use of imaging in pre-operative VA assessment
Z. Khawaja
Assessment of UK trends in VA imaging for hemodialyzed patients
Benefit/risk assessment of contrast-enhanced MRI for VA imaging
Diagnostic test accuracy review on VA imaging techniques
R. Ross, R. Jones
Comparison of US protocols for VA assessment

8. Roles of the Team Members
S. Gandy, S. Bell, R. Jones
Test and validation of MRI protocols for VA assessment
Retrospective analysis of data from patients who underwent an MRI for VA assessment
JS. Raynaud, E. Lancelot
Evaluation of the safety of MR contrast agents used for VA assessment in hemodialyzed patients

9. Mid-Term Review – Workpackage 3
Part 1: presentation of the research team
Part 2: individual report

10. E. Lancelot – Individual Report
Background
1990: PharmD – Paris
1996: PhD in neuropharmacology – Paris
1997: Post-doctoral studies in neurochemistry – MGH, Boston
: Head of Biology Research Department – Guerbet, Paris
Experimental pharmacokinetic, pharmacodynamic and toxicological studies on contrast media
Molecular imaging in cardiovascular, tumoral, inflammatory and neurodegenerative diseases
Management of a team of 20 collaborators
: Head of Medical & Regulatory Affairs – Guerbet, Paris
Management of MRA managers in 11 European subsidiaries
Coordination of RA, PV, QA, clinical studies, medical information
Expertise in contrast media safety and efficacy

11. E. Lancelot – Individual Report
Scientific activities related to the safety of GBCAs
Meta-analysis of the dose of GBCAs reported in the publications
Meta-analysis of the published observational studies (PMSs) on the tolerance of GBCAs
Demonstration of the prolonged excretion of linear GBCAs from the Human body as compared to the macrocyclic ones
Investigator-initiated studies on the long-term accumulation of linear (not macrocyclic) GBCAs in patients’ brains
Scientific activities related to VA imaging
Attendance to VA sessions in congresses (ECR, VASA, VASBI, VAS)
Education on VA imaging during secondment in Dundee
Review of publication manuscripts of ReDVA secondees

12. E. Lancelot – Individual Report
Management activities related to ReDVA
Coordination of the WP3
Organization of the first-year meeting in Paris
Responsible for any question about ReDVA inside Guerbet (communication, budget, resources, knowledge exchange…)
Supervision of the secondees’ activity
Knowledge exchange – secondees training
Overview on GBCAs: physicochemical characteristics, impact on safety (e.g. ADRs), impact on efficacy (e.g. breast lesion characterization), approved dose vs. overdose…
Management of medical information
Animal facilities and laboratories for experimental imaging studies

13. E. Lancelot – Individual Report
Impact
Exploration of a new medical field (VA in HD patients)
 intellectually challenging
Identification of the medical needs and the potential utility of new imaging techniques with contrast agents
 innovative, stimulating
Understanding of the multidisciplinary process of care of HD patients
 fruitful interface with surgeons, interventional radiologists, nephrologists
Assessment of contrast agent safety and efficacy in at-risk patients
 opportunity for expanding our knowledge
International project
 opportunity for sharing knowledge and experience

14. Thank you for your attention
ReDVA Mid-Term Review
Thank you for your attention