Clinical trial protocol for TARDOX: a phase I study to investigate the feasibility of targeted release of lyso-thermosensitive liposomal doxorubicin (ThermoDox®) using focused ultrasound in patients with liver tumours.
- Submitting institution
-
University of Oxford
- Unit of assessment
- 12 - Engineering
- Output identifier
- 9550
- Type
- D - Journal article
- DOI
-
10.1186/s40349-017-0104-0
- Title of journal
- Journal of Therapeutic Ultrasound
- Article number
- 28
- First page
- 28
- Volume
- 5
- Issue
- 1
- ISSN
- 2050-5736
- Open access status
- Compliant
- Month of publication
- November
- Year of publication
- 2017
- URL
-
-
- Supplementary information
-
-
- Request cross-referral to
- -
- Output has been delayed by COVID-19
- No
- COVID-19 affected output statement
- -
- Forensic science
- No
- Criminology
- No
- Interdisciplinary
- Yes
- Number of additional authors
-
8
- Research group(s)
-
-
- Proposed double-weighted
- No
- Reserve for an output with double weighting
- No
- Additional information
- Describes the innovative trial design, monitoring techniques, sampling strategies and analysis methods to ensure the safety and efficacy of a novel device+drug approach utilizing ultrasound-mediated hypethermia to trigger drug release from thermosensitive liposomes for the first time in humans. This paper provides a template for researchers to clinically appraise their own drug+device combinations. It received an Altmetric attention score of 38 (top 5% of research outputs) and 5 news outlets highlighted the collaboration with US pharma Celsion (Senior Vice President and Chief Medical Officer, Celsion available to corroborate). The successful trial was published in the top-ranked oncology journal (10.1016/S1470-2045(18)30332-2).
- Author contribution statement
- -
- Non-English
- No
- English abstract
- -
