Anal Cancer, Bladder Cancer, Cervical Cancer, Colorectal Carcinoma, Lung Cancer (Including Metastatic Cancer), Neoplasm Recurrence, Local, Ovarian Cancer, Prostate Cancer, Renal Cancer
Conditions
Keywords
Irreversible electroporation (IRE), Colorectal Carcinoma, Local treatment, Tumor Ablation, Neoplasm Recurrence, Pelvic Tumor Recurrence
Brief summary
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.
Detailed description
Retrospective data from December 2012 to April 2025, followed by prospective collection of new cases.
Interventions
PROCEDUREIrreversible electroporation
Irreversible electroporation
Sponsors
Amsterdam UMC, location VUmc
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Adverse Events (CTCAE v5.0) | Assessed up to 5 years. | Safety of IRE, assessed by the rate and severity of adverse events per procedure and per patient, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Incidence and Classification of Nerve Injury (Seddon Classification) | Assessed up to 5 years. | Nerve injuries related to IRE, assessed per procedure and per patient, classified according to Seddon's classification as neurapraxia, axonotmesis, or neurotmesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) per patient. | Assessed up to 10 years | Overall survival is defined as the time from IRE procedure to the time of death due to any cause or to the last day of follow up (censored). |
| Progression-free survival (PFS; per patient analysis) | Up to 10 years | The time until the date of unequivocal disease progression (local site recurrence or metastatic disease) or death from any cause, whichever occurs first, assessed up to 10 years. |
| Distant tumor progression-free survival (DPFS) per patient. | 10 years | Distant tumor progression-free survival is defined as the time from randomization to the time of unequivocal distant tumor progression. |
| Local tumor progression-free survival (LTPFS) per patient and per tumor. | 10 years | Local tumor progression-free survival is defined as the time from IRE procedure to the time of unequivocal local tumor progression. |
| Technical success | IRE procedure duration (actual treatment phase): 30 minutes to 2 hours | Proper placement and operation of the electrodes, the precise delivery of electrical pulses to the targeted tissue, and ensuring the parameters (such as voltage, pulse duration, and frequency) are correctly applied according to the protocol. |
Countries
Netherlands
Contacts
CONTACTSonia Triggiani, Radiologist
Outcome results
None listed