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

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

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

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

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

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

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

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

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

E. Lancelot – Individual Report Background 1990: PharmD – Paris 1996: PhD in neuropharmacology – Paris 1997: Post-doctoral studies in neurochemistry – MGH, Boston 1998-2009: 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 2010-2015: 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

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

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

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

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