This is a phase 1 non-randomised trial to investigate the feasibility of targeted release of Doxorubicin from Lyso-thermosensitive Liposomal (LTSL) Doxorubicin (ThermoDox (R) using focused ultrasound in patients with liver metastases from lung, breast or colorectal primary tumours.
A Proof of Concept Study to Investigate the Feasibility of Targeted Release of Doxorubicin from Lyso-thermosensitive Liposomal (LTSL) Doxorubicin (ThermoDox®) Using Focused Ultrasound in Patients with Primary or Secondary Liver Tumours.
Phase 1 prospective non-randomised safety cohort study with all patients recruited from a single UK site (Oxford). The study has an open label design with all participants receiving ThermoDox® and HIFU. The study is split into two parts. Part I is required to identify optimal HIFU exposure parameters using real time thermometry data from an implanted thermistor. Part II does not require thermistor implantation and is designed to more accurately reflect how the therapy would be implemented in clinical practice. All evaluable participants from both Part I and Part II will be included in the endpoint analysis.
To determine whether targeted release of doxorubicin from ThermoDox® (‘drug’) using mild hyperthermia generated non-invasively by focused ultrasound (HIFU) is feasible in cancer patients.
Planned accrual completion: Mar 2017
Trial duration: 3 years