VEROnA

• Research type

  Research Study

• Full title

  A pilot, open label, single-arm, phase 0, window of opportunity study of vandetanib-eluting radiopaque embolic beads (BTG-002814) in patients with resectable liver malignancies

• IRAS ID

  217376

• Contact name

  Ricky Sharma

• Contact email

  ricky.sharma@ucl.ac.uk

• Sponsor organisation

  Biocompatibles UK Ltd

• Eudract number

  2016-004164-19

• Duration of Study in the UK

  1 years, 6 months, 31 days

• Research summary

  We want to see if BTG-002814 is safe. This is the first time that BTG-002814 has been given to humans.
  BTG-002814 is made up of tiny beads linked to an anticancer drug called vandetanib. Treatment with BTG-002814 is called drug-eluting bead transarterial chemoembolisation (DEB-TACE). It involves injecting BTG-002814 into an artery leading directly to the liver tumour(s).
  DEB-TACE works in two ways:
  - The beads get stuck in small blood vessels leading into the tumour. This stops blood flow and the cancer cells die because they do not get the oxygen and nutrients they need to survive.
  - The beads release the anticancer drug into the tumour where it can get at the cancer cells and kill them.

  The main reasons for doing this study are:
  - To find out if giving this treatment is safe and if any side effects are manageable for patients.
  - To measure how much vandetanib is in the blood and liver tissue after treatment

  We also plan to:
  - Look at the distribution of BTG-002814 within the body using CT and MRI scans
  - Look at the effect of BTG-002814 on the liver tissue removed during surgery
  - Assess changes in blood-flow to the tumour following treatment using MRI
  - Study blood biomarkers following treatment with BTG-002814 (looking at certain features in the blood which may help identify suitable patients for this therapy in the future).
  - Use 3D modelling to compare the distribution of BTG-002814 seen on imaging with the distribution found in liver tissue.

  Patients will receive one DEB-TACE treatment with BTG-002814 before the usual treatment of surgery (there will be no delay in the timing of the surgery).

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  17/LO/0011

• Date of REC Opinion

  23 Jan 2017

• REC opinion

  Favourable Opinion