Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study)
Recruiting · NCT07782164 · Observational (researchers observe without assigning treatment) · Lead sponsor: Amsterdam UMC, location VUmc
View the official record on ClinicalTrials.gov →Interventions studied
Irreversible electroporation
What this trial is about
The goal of this single-center observational cohort study, based on a registry combining retrospectively and prospectively collected data, is to investigate the short- and long-term effects of irreversible electroporation (IRE) in men and women over the age of 18 who receive IRE for recurrence of pelvic tumors not suitable for other local treatment options such as surgery, thermal ablation, and radiotherapy. The main question it aims to answer is whether IRE is safe in this population, and secondarily, whether it is effective in controlling local tumor recurrence.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Measurable disease described on pre-treatment imaging (CT/MRI/PET-CT) (max 6 weeks prior);
- IRE of a recurrent pelvic tumor;
- Unsuitable for other local therapies (surgery/stereotactic body radiation therapy) as described during the multidisciplinary tumor board;
Exclusion criteria
- If the treated tumor was biopsied directly prior to MWA and pathology proves the lesion to represent a benign entity;
- Inadequate or insufficient data registered;
- Inadequate or insufficient follow-up;
Where it is running
1 location listed.
- Amsterdam UMC - Amsterdam, North Holland, Netherlands