[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653141":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":48,"studyPopulation":49,"armGroups":46,"interventions":50,"overallOfficials":46,"centralContacts":54,"locations":61,"responsibleParty":82,"collaborators":46,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":46,"enrollmentInfo":96,"targetDuration":99,"studyType":100,"phases":46,"briefSummary":101,"conditions":102,"keywords":113,"overallStatus":64,"whyStopped":46,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":36},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.",{"measure":14,"description":15,"timeFrame":12},"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.",[17,21,25,29,32],{"measure":18,"description":19,"timeFrame":20},"Overall survival (OS) per patient.","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).","Assessed up to 10 years",{"measure":22,"description":23,"timeFrame":24},"Progression-free survival (PFS; per patient analysis)","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.","Up to 10 years",{"measure":26,"description":27,"timeFrame":28},"Distant tumor progression-free survival (DPFS) per patient.","Distant tumor progression-free survival is defined as the time from randomization to the time of unequivocal distant tumor progression.","10 years",{"measure":30,"description":31,"timeFrame":28},"Local tumor progression-free survival (LTPFS) per patient and per tumor.","Local tumor progression-free survival is defined as the time from IRE procedure to the time of unequivocal local tumor progression.",{"measure":33,"description":34,"timeFrame":35},"Technical success","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.","IRE procedure duration (actual treatment phase): 30 minutes to 2 hours",[37,41],{"measure":38,"description":39,"timeFrame":40},"Length of Post-procedural Hospital Stay","Length of hospital stay following the IRE procedure, in days. Collected to descriptively explore potential associations with lesion and patient characteristics (e.g., lesion type, tumor location).","From end of procedure to hospital discharge, assessed up to 30 days.",{"measure":42,"description":43,"timeFrame":44},"Tumor markers","Correlation between serum tumor marker levels (e.g., CA19-9, CEA) and radiological tumor response following IRE. Tumor marker dynamics will be explored as potential biomarkers for early treatment efficacy and recurrence.","Baseline to 10 years",{"allocation":46,"interventionModel":46,"interventionModelDescription":46,"primaryPurpose":46,"observationalModel":47,"timePerspective":6,"maskingInfo":46},null,"COHORT","Retrospective data from December 2012 to April 2025, followed by prospective collection of new cases.","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.",[51],{"type":52,"name":53,"description":53,"armGroupLabels":46,"otherNames":46},"PROCEDURE","Irreversible electroporation",[55],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":60},"Sonia Triggiani, Radiologist","CONTACT","+393406763760","+39","sonia.triggiani@policlinico.mi.it",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Amsterdam UMC","RECRUITING","Amsterdam","North Holland","1118 HV","Netherlands","NL",{"type":71,"coordinates":72},"Point",[73,74],4.88969,52.37403,{"lat":74,"lon":73},[77],{"name":78,"role":57,"phone":79,"phoneExt":80,"email":81},"Danielle Vos, MD","020-4444444","+31","interventieradiologie@amsterdamumc.nl",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"PRINCIPAL_INVESTIGATOR","M.R. Meijerink","Professor","100653141","efficacy-of-irreversible-electroporation-ire-for-treating-recurrent-pelvic-tumors-pelfire-study-100653141",false,"NCT07782164","Efficacy of Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study)","Irreversible Electroporation (IRE) of Recurrent Pelvic Tumors: the PELFIRE Study.","PELFIRE","Inclusion Criteria:\n\n* Measurable disease described on pre-treatment imaging (CT\u002FMRI\u002FPET-CT) (max 6 weeks prior);\n* IRE of a recurrent pelvic tumor;\n* Unsuitable for other local therapies (surgery\u002Fstereotactic body radiation therapy) as described during the multidisciplinary tumor board;\n\nExclusion Criteria:\n\n* If the treated tumor was biopsied directly prior to MWA and pathology proves the lesion to represent a benign entity;\n* Inadequate or insufficient data registered;\n* Inadequate or insufficient follow-up;","ALL","18 Years",{"count":97,"type":98},27,"ESTIMATED","5 Years","OBSERVATIONAL","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.",[103,104,105,106,107,108,109,110,111,112],"Colorectal Carcinoma","Pelvic Cancer","Pelvic Tumor Recurrence","Renal Cancer","Bladder Cancer","Cervical Cancer","Prostate Cancer","Ovarian Cancer","Lung Cancer (Including Metastatic Cancer)","Anal Cancer",[114,103,115,116,117,105],"Irreversible electroporation (IRE)","Local treatment","Tumor Ablation","Neoplasm Recurrence","2026-08-21",{"date":120,"type":121},"2026-08-24","ACTUAL",{"date":123,"type":121},"2025-04-18",{"date":125,"type":98},"2028-07",{"name":5,"class":6},1]