Trial Details
Trial status:
Recruitment start date:
Biocompatibles UK Ltd
Biocompatibles UK Ltd
Chief Investigator:
Prof Ricky Sharma
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
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
Design: VEROnA is a pilot, open label, single arm, Phase 0 window of opportunity study of vandetanib eluting radiopaque embolic beads.
Treatment: Single treatment arm. Patients will received one treatment of BTG-002814 (1mL BTG-002814 containing 100mg vandetanib). 
Key inclusion/exclusion criteria: Patients must have resectable HCC or resectable liver metastases from CRC and a candidate for liver surgery with a low risk for surgical morbidity and mortality from liver surgery. Patients must have adequate haematological, liver and renal function.Patients can’t have had any systemic chemotherapy within 3 months prior to screening or previous treatment with transarterial embolization of the liver, radiotherapy or ablation therapy to the liver or prior yttrium-90 microsphere therapy. 
Duration of recruitment: This study aims to treat 12 patients over the duration of 18 months. The study duration per patient is up to 9 weeks. 
The primary aims of VEROnA are to assess the safety and tolerability of treatment with BTG-002814 and to measure the plasma and resected liver tissue concentrations of vandetanib and N-desmethyl vandetanib following treatment with BTG-002814.

The secondary aims of VEROnA are to evaluate the anatomical distribution of BTG-002814 on non-contrast enhanced imaging using 4D CT. Evaluate histopathological features in the surgical specimen following treatment with BTG-002814. Assess changes in blood flow on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) following treatment with BTG-002814.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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