Clinical trial · Observational
Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study)
Irreversible Electroporation (IRE) of Recurrent Pelvic Tumors: the PELFIRE Study.
NCT07782164CI-TRIAL-00124287PELFIRErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Cancer (Including Metastatic Cancer) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Neoplasm Recurrence, Local | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible electroporation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Incidence and Severity of Adverse Events (CTCAE v5.0)
- timeFrame
- Assessed up to 5 years.
- description
- 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.
- measure
- Incidence and Classification of Nerve Injury (Seddon Classification)
- timeFrame
- Assessed up to 5 years.
- description
- Nerve injuries related to IRE, assessed per procedure and per patient, classified according to Seddon's classification as neurapraxia, axonotmesis, or neurotmesis.
Secondary outcomes (5)
- measure
- Overall survival (OS) per patient.
- timeFrame
- Assessed up to 10 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (8)
- BACKGROUNDLuo X, Qin Z, Tao H, Shi J, Fang G, Li Z, Zhou X, Chen J, Xu K, Zeng J, Niu L. The Safety of Irreversible Electroporation on Nerves Adjacent to Treated Tumors. World Neurosurg. 2017 Dec;108:642-649. doi: 10.1016/j.wneu.2017.09.049. Epub 2017 Sep 18. PMID 28927918
- BACKGROUNDSchoellnast H, Monette S, Ezell PC, Maybody M, Erinjeri JP, Stubblefield MD, Single G, Solomon SB. The delayed effects of irreversible electroporation ablation on nerves. Eur Radiol. 2013 Feb;23(2):375-80. doi: 10.1007/s00330-012-2610-3. Epub 2012 Aug 16. PMID 23011210
- BACKGROUNDNarayanan G, Mahendra AM, Gentile NT, Schiro BJ, Gandhi RT, Pena CS, Dijkstra M. Safety and Effectiveness of Irreversible Electroporation in Lymph Node Metastases. Cardiovasc Intervent Radiol. 2024 Aug;47(8):1066-1073. doi: 10.1007/s00270-024-03795-w. Epub 2024 Jun 28. PMID 38943032
- BACKGROUNDSeddon HJ. A Classification of Nerve Injuries. Br Med J. 1942 Aug 29;2(4260):237-9. doi: 10.1136/bmj.2.4260.237. No abstract available. PMID 20784403
- BACKGROUNDvan den Bos W, Scheffer HJ, Vogel JA, Wagstaff PG, de Bruin DM, de Jong MC, van Gemert MJ, de la Rosette JJ, Meijerink MR, Klaessens JH, Verdaasdonk RM. Thermal Energy during Irreversible Electroporation and the Influence of Different Ablation Parameters. J Vasc Interv Radiol. 2016 Mar;27(3):433-43. doi: 10.1016/j.jvir.2015.10.020. Epub 2015 Dec 17. PMID 26703782
- BACKGROUNDScheffer HJ, Nielsen K, de Jong MC, van Tilborg AA, Vieveen JM, Bouwman AR, Meijer S, van Kuijk C, van den Tol PM, Meijerink MR. Irreversible electroporation for nonthermal tumor ablation in the clinical setting: a systematic review of safety and efficacy. J Vasc Interv Radiol. 2014 Jul;25(7):997-1011; quiz 1011. doi: 10.1016/j.jvir.2014.01.028. Epub 2014 Mar 18. PMID 24656178
- BACKGROUNDVroomen LGPH, Scheffer HJ, Melenhorst MCAM, van Grieken N, van den Tol MP, Meijerink MR. Irreversible Electroporation to Treat Malignant Tumor Recurrences Within the Pelvic Cavity: A Case Series. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1631-1640. doi: 10.1007/s00270-017-1657-6. Epub 2017 May 3.