None listed
Conditions
Brief summary
In cases where patients have inoperable tumours, direct destruction of focal tumours using various energy sources such as heat (radiofrequency ablation, microwaves), cold (cryotherapy) or ethanol injection have been used for the last twenty years. A needle is placed into the tumour under image guidance in a similar way to taking a biopsy. The energy used, heat or cold, destroys the tumour. Currently not all inoperable tumours can be treated in this way because tumours may lie close to vital structures that may be affected and therefore pose a large risk to patients. The new technology, irreversible electroporation, does not use heat or cold and therefore spares vital structures. Direct electrical current is used to destroy the outer membrane of the tumour cells. We are testing the safety and effectiveness of this form of ablation.
Interventions
The intervention is ablation using Irreversible electroporation (direct current) which disrupts the cell membrane killing the tumour cells.
The whole procedure takes between 2 to 3 hours. Once the needle electrodes are in place the ablation takes approximately one minute. Depending on the size of the tumour the needle electrodes may be repositioned and further ablations (2 to approximately 10) may be performed. If complete ablation is not achieved a second procedure can be performed.
Sponsors
The Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Ages 35-85 years, Signed informed consent, Failed conventional treatment, Ability to visualize cancer foci adequately on imaging.
Exclusion criteria
Patients not deemed suitable for ablation procedure.
Outcome results
None listed