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Imaging Biomarkers (IBs) for Safer Drugs: Validation of Translational Imaging Methods in Drug Safety Assessment - Sofia ref.: 116106

Deliverables

Manuscript on novel 89Zr-GLP-1 peptide conjugation

An ARRIVE-compliant manuscript submitted for open-access publication describing the design and synthesis the GLP-1 site-specifically conjugated to the optimised 89Zr chelate, the design and synthesis the GLP-1 site-specifically conjugated to IRDye 800CW, molecular integrity and stability of GLP-1 conjugates analytically verified through LC-MS, in vitro evaluation of properties of 89Zr-labelled GLP-1 conjugate: chemical purity, stability, degradation, suitability for in vivo administration, in vivo evaluation of properties of 89Zr-labelled GLP-1 conjugate and IRDye 800CW GLP-1 conjugate Responsible for coordinating and assembling entire manuscript: Dijon Verification: (1) PDF of manuscript; (2) Email from journal acknowledging receipt of manuscript; (3) Minutes of WP4 meeting prospectively justifying sample size for animal experiments; (4) A copy of the page on the TRISTAN data inventory (5.0.D1) which shows a record for the data acquired in order to generate this deliverable; (5) url of the site (5.0.D4) containing any SOPs and any exemplar data-sets associated with this deliverable. Responsible for mouse imaging: Nijmegen Responsible for analytic verification: Nijmegen GNG 4.1.G4: Thermodynamic and kinetic stability of 89Zr in these novel chelates in blood (in vitro) as well as physicochemical properties of labeled compounds should jusify further animal experiments Site-specific conjugated 89Zr-conjugated GLP-1 and the fluorescent analogue, in vitro are impressive enough to justify further animal experiments Verification: Minutes of WP4 meeting Consequence: If conjugate is unimpressive, previously existing Zr chelates will be used for further studies Date: M18

Manuscript on physician approaches to DIILD

A survey of physician approaches to treatment of DIILD from drugs with known DIILD risk, submitted for open-access publication Responsible for coordinating and assembling entire manuscript: Sheffield Responsible for contributing Sheffield, Bioxydyn, Manchester, Verification: (1) Pdf of manuscript; (2) Email from journal acknowledging receipt of manuscript

Manuscript on simplified IL2 labeling method

A manuscript submitted for open-access publication describing a simplified method that could be applied in multicentre studies to produce a 68Ga or 18F-labelled IL2-based PET tracer. Responsible for coordinating and assembling entire manuscript: Nijmegen Responsible for contributing: Groningen Verification: (1) PDF of manuscript; (2) Email from journal acknowledging receipt of manuscript; (3) A copy of the page on the TRISTAN data inventory (5.0.D1) which shows a record for the data acquired in order to generate this deliverable; (4) url of the site (5.0.D4) containing any SOPs and any exemplar data-sets associated with this deliverable. GNG 4.3.G1: a simplified method that could be applied in multicentre studies to produce a 68Ga or 18F-labelled IL2-based PET tracer Verification: Minutes of WP4 meeting Consequence: IL2 tracer will not be used in 4.3.D2 Date: M18

Manuscript for gadoxetate relaxivities

A manuscript submitted for open-access publication reporting the different relaxivities of gadoxetate between extra- and intracellular space characterised by in vitro studies at relevant field strengths. May be either a stand-alone manuscript or alternatively included as a section or supplementary material in a broader manuscript. Responsible for coordinating work assembling entire manuscript: Bayer Responsible for contributing data: Bayer, MSD, Sanofi Verification: (1) pdf of manuscript; (2) email from journal acknowledging receipt of submitted manuscript; (3) A copy of the page on the TRISTAN data inventory (5.0.D1) which shows a record for the data acquired in order to generate this deliverable.

Publications

Drug-Induced Liver Toxicity

Author(s): Minjun Chen, Yvonne Will
Published in: Methods in Pharmacology and Toxicology, 2018
DOI: 10.1007/978-1-4939-7677-5

89 Zr-Immuno-Positron Emission Tomography in Oncology: State-of-the-Art 89 Zr Radiochemistry

Author(s): Sandra Heskamp, René Raavé, Otto Boerman, Mark Rijpkema, Victor Goncalves, Franck Denat
Published in: Bioconjugate Chemistry, Issue 28/9, 2017, Page(s) 2211-2223, ISSN 1043-1802
DOI: 10.1021/acs.bioconjchem.7b00325

Drug-Induced Interstitial Lung Disease: A Systematic Review

Author(s): Sarah Skeoch, Nicholas Weatherley, Andrew Swift, Alexander Oldroyd, Christopher Johns, Conal Hayton, Alessandro Giollo, James Wild, John Waterton, Maya Buch, Kim Linton, Ian Bruce, Colm Leonard, Stephen Bianchi, Nazia Chaudhuri
Published in: Journal of Clinical Medicine, Issue 7/10, 2018, Page(s) 356, ISSN 2077-0383
DOI: 10.3390/jcm7100356

Synthesis and evaluation of zirconium-89 labelled and long-lived GLP-1 receptor agonists for PET imaging

Author(s): Christian Borch Jacobsen, René Raavé, Marie Østergaard Pedersen, Pierre Adumeau, Mathieu Moreau, Ibai E. Valverde, Inga Bjørnsdottir, Jesper Bøggild Kristensen, Mette Finderup Grove, Kirsten Raun, James McGuire, Victor Goncalves, Sandra Heskamp, Franck Denat, Magnus Gustafsson
Published in: Nuclear Medicine and Biology, Issue 82-83, 2020, Page(s) 49-56, ISSN 0969-8051
DOI: 10.1016/j.nucmedbio.2019.11.006

Tracers for non-invasive radionuclide imaging of immune checkpoint expression in cancer

Author(s): Peter Wierstra, Gerwin Sandker, Erik Aarntzen, Martin Gotthardt, Gosse Adema, Johan Bussink, René Raavé, Sandra Heskamp
Published in: EJNMMI Radiopharmacy and Chemistry, Issue 4/1, 2019, ISSN 2365-421X
DOI: 10.1186/s41181-019-0078-z

Clinical-grade N-(4-[18F]fluorobenzoyl)-interleukin-2 for PET imaging of activated T-cells in humans

Author(s): Elly L. van der Veen, Inês F. Antunes, Petra Maarsingh, Janet Hessels-Scheper, Rolf Zijlma, Hendrikus H. Boersma, Annelies Jorritsma-Smit, Geke A. P. Hospers, Elisabeth G. E. de Vries, Marjolijn N. Lub-de Hooge, Erik F. J. de Vries
Published in: EJNMMI Radiopharmacy and Chemistry, Issue 4/1, 2019, ISSN 2365-421X
DOI: 10.1186/s41181-019-0062-7

Direct comparison of the in vitro and in vivo stability of DFO, DFO* and DFOcyclo* for 89Zr-immunoPET

Author(s): René Raavé, Gerwin Sandker, Pierre Adumeau, Christian Borch Jacobsen, Floriane Mangin, Michel Meyer, Mathieu Moreau, Claire Bernhard, Laurène Da Costa, Adrien Dubois, Victor Goncalves, Magnus Gustafsson, Mark Rijpkema, Otto Boerman, Jean-Claude Chambron, Sandra Heskamp, Franck Denat
Published in: European Journal of Nuclear Medicine and Molecular Imaging, Issue 46/9, 2019, Page(s) 1966-1977, ISSN 1619-7070
DOI: 10.1007/s00259-019-04343-2

Experimental and quantitative imaging techniques in interstitial lung disease

Author(s): Nicholas D Weatherley, James A Eaden, Neil J Stewart, Brian J Bartholmai, Andrew J Swift, Stephen Mark Bianchi, Jim M Wild
Published in: Thorax, Issue 74/6, 2019, Page(s) 611-619, ISSN 0040-6376
DOI: 10.1136/thoraxjnl-2018-211779

Repeatability and reproducibility of longitudinal relaxation rate in 12 small-animal MRI systems

Author(s): John C. Waterton, Catherine D.G. Hines, Paul D. Hockings, Iina Laitinen, Sabina Ziemian, Simon Campbell, Michael Gottschalk, Claudia Green, Michael Haase, Katja Hassemer, Hans-Paul Juretschke, Sascha Koehler, William Lloyd, Yanping Luo, Irma Mahmutovic Persson, James P.B. O'Connor, Lars E. Olsson, Kashmira Pindoria, Jurgen E. Schneider, Steven Sourbron, Denise Steinmann, Klaus Strobel, Sirisha Tad
Published in: Magnetic Resonance Imaging, Issue 59, 2019, Page(s) 121-129, ISSN 0730-725X
DOI: 10.1016/j.mri.2019.03.008

Feasibility of PET/CT system performance harmonisation for quantitative multicentre 89Zr studies

Author(s): Andres Kaalep, Marc Huisman, Terez Sera, Danielle Vugts, Ronald Boellaard
Published in: EJNMMI Physics, Issue 5/1, 2018, ISSN 2197-7364
DOI: 10.1186/s40658-018-0226-7

How consistently do physicians diagnose and manage drug-induced interstitial lung disease? Two surveys of European ILD specialist physicians

Author(s): James A. Eaden, Sarah Skeoch, John C. Waterton, Nazia Chaudhuri, Stephen M. Bianchi
Published in: ERJ Open Research, Issue 6/1, 2020, Page(s) 00286-2019, ISSN 2312-0541
DOI: 10.1183/23120541.00286-2019

Noninvasive Preclinical and Clinical Imaging of Liver Transporter Function Relevant to Drug-Induced Liver Injury

Author(s): J. Gerry Kenna, John C. Waterton, Andreas Baudy, Aleksandra Galetin, Catherine D. G. Hines, Paul Hockings, Manishkumar Patel, Daniel Scotcher, Steven Sourbron, Sabina Ziemian, Gunnar Schuetz
Published in: Drug-Induced Liver Toxicity, 2018, Page(s) 627-651
DOI: 10.1007/978-1-4939-7677-5_30