Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study)

NCT07782164 | Recruiting

• 1 other identifier: 2025.0233
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Carcinoma; Renal Cancer; Bladder Cancer; Cervical Cancer; Prostate Cancer; Lung Cancer (Including Metastatic Cancer); Ovarian Cancer; Anal Cancer; Neoplasm Recurrence, Local

Keywords

Irreversible electroporation (IRE); Colorectal Carcinoma; Local treatment; Tumor Ablation; Neoplasm Recurrence; Pelvic Tumor Recurrence

Outcome Measures

Primary Outcomes (2)

• Incidence and Severity of Adverse Events (CTCAE v5.0)

  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.

  Assessed up to 5 years.

• Incidence and Classification of Nerve Injury (Seddon Classification)

  Nerve injuries related to IRE, assessed per procedure and per patient, classified according to Seddon's classification as neurapraxia, axonotmesis, or neurotmesis.

  Assessed up to 5 years.

Secondary Outcomes (5)

• Overall survival (OS) per patient.

  Assessed up to 10 years

• Progression-free survival (PFS; per patient analysis)

  Up to 10 years

• Distant tumor progression-free survival (DPFS) per patient.

  10 years

• Local tumor progression-free survival (LTPFS) per patient and per tumor.

  10 years

• Technical success

  IRE procedure duration (actual treatment phase): 30 minutes to 2 hours

Other Outcomes (2)

• Length of Post-procedural Hospital Stay

  From end of procedure to hospital discharge, assessed up to 30 days.

• Tumor markers

  Baseline to 10 years

Interventions

Irreversible electroporation PROCEDURE

Irreversible electroporation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients treated with irreversible electroporation (IRE) for recurrent pelvic tumors at Amsterdam UMC starting from December 2012, identified from a dedicated institutional registry. Patients had recurrent pelvic disease not amenable to other local treatment options (surgery, stereotactic body radiotherapy, or thermal ablation), as determined by a multidisciplinary tumor board including medical oncology, radiation oncology, surgical oncology, diagnostic and interventional radiology, and pathology.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1118 HV, Netherlands

RECRUITING

Related Publications (8)

• Luo 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 BACKGROUND

• Schoellnast 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 BACKGROUND

• Narayanan 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 BACKGROUND

• Seddon 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 BACKGROUND

• van 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 BACKGROUND

• Scheffer 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 BACKGROUND

• Vroomen 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.

  PMID: 28470395 BACKGROUND

• Niessen C, Jung EM, Schreyer AG, Wohlgemuth WA, Trabold B, Hahn J, Rechenmacher M, Stroszczynski C, Wiggermann P. Palliative treatment of presacral recurrence of endometrial cancer using irreversible electroporation: a case report. J Med Case Rep. 2013 May 13;7:128. doi: 10.1186/1752-1947-7-128.

  PMID: 23668891 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Kidney Neoplasms; Urinary Bladder Neoplasms; Uterine Cervical Neoplasms; Prostatic Neoplasms; Ovarian Neoplasms; Lung Neoplasms; Anus Neoplasms; Neoplasm Recurrence, Local; Recurrence

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Rectal Neoplasms; Anus Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Central Study Contacts

Sonia Triggiani, Radiologist

CONTACT

+393406763760; sonia.triggiani@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 24, 2026
• Study Start: April 18, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)