Phase 0 study of vandetanib-eluting radiopaque embolics as a pre-operative embolization treatment in patients with resectable liver malignancies


Footnotes

Funding: Biocompatibles UK Ltd., National Institute for Health Research University College London Hospitals Biomedical Centre, University College London Cancer Research UK Experimental Cancer Medicines Centre (Award C416/A25145)

Presentations: The material in this manuscript has not been presented at a SIR Annual Scientific Meeting.

Declaration of interests

RAS declares consultancy with Affidea, Astra Zeneca, Boston Scientific, BTG plc, Cancer Research Technology, DeepMind, Eisai, Sirtex, Terumo and Varian. RAS is a full-time employee of Varian Medical Systems. TM declares consultancy with BTG plc and is part funded by NIHR UCLH Biomedical Research Centre. BRD declares advisor role to Sirtex. SB declares consultancy for Angiodynamics. ZAB, PEW, SC, SR, ALL, PC and EB were employed by BTG plc and ZAB, PEW, SC, SR, PC and EB are now employees of Boston Scientific Corporation. MZT is supported by an EPSRC Early Career Fellowship (EP/L006472/1). DJS is supported by a British Heart Foundation Intermediate Basic Science Research Fellowship (FS/15/33/31608) and a Medical Research Council project grant (MR/R026416/1).

Acknowledgements: This study was funded by research grants from Biocompatibles UK Ltd. (BTG) to University College London (PI: RAS). Trial management was performed by UCL CTC with invaluable support from Sandy Beare, Laura White, Jessica Smith, Michelle Hung, Allan Hackshaw and Elizabeth Chang. Biomarker analysis was performed at UCL ECMC GCLP Facility with input from Leah Ensell, Alexia Gali, and Adam Westhorpe. Plasma and tissue vandetanib levels were analysed at York Bioanalytical Solutions Ltd by Riyam Al-Khaily, Ian Smith, Niall Harvey and Andrew Wills. All perfusion imaging procedures were performed at University College Hospital London (UCLH) with assistance from Laura Parry, Colette Keohane, Lucy Caselton, Magdelena Sokolska, David Hawkes and Jorge Cardoso. Support was provided from Mark Condron (Canon/Toshiba) for the perfusion CT protocols and analysis. Interventional radiology procedures and drug delivery were all performed at UCLH with assistance from Sally Vrebac and Kate Richards. All trial visits were performed at UCLH and the Royal Free Hospital with assistance from the Shiela Quiapo, Pamela Rice, Micehlle Budo, John Kilner Tesha Suddason and Amir Gander. We thank the members of the Safety Review Committee which included Daniel Hochhauser and Allan Hackshaw. Finally, we are profoundly grateful to the patients who participated in this trial and the relatives for their support.

Author contributions:

RAS, SB, MC, DS, BRD, JH, ZAB, PEW, PC, MJ, and TM contributed to the study concept. All authors were responsible for writing the study protocol and standard operating procedures.

LB, HT, SAZ, SF, BRD, ZAB, PEW, SC, EB, ALL, TM and RAS were responsible for writing this paper. SR and NC were responsible for the statistical plan. All authors checked and approved the final version of this study.

Role of the funding source

BTG provided financial support for this study, and participated in the study design, conduct, analysis and interpretation of data, in addition to review and approval of the final manuscript. Data were collected by the investigators and their research staff. National Institute for Health Research University College London Hospitals Biomedical Centre and University College London Cancer Research UK Experimental Medicines Centre provided infrastructure support, research staff and consumable costs. Statistical analysis was performed by the trial team at Cancer Research UK and UCL Cancer Trials Centre, overseen by a statistician employed by BTG. All authors had full access to the data on request. The paper was drafted by the first and last authors and was revised in collaboration with all authors. The final author had full access to the data in the study and had final responsibility for the decision to submit for publication.



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