Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT02567734
Status:
UNKNOWN
Last Update Posted:
2015-12-28
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-24', 'studyFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2015-10-02', 'lastUpdatePostDateStruct': {'date': '2015-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effective rate of IRE ablation', 'timeFrame': 'up to 12 months after the procedures', 'description': 'The procedure-related result will be assess by the size，blood supply，metabolism of the tumors. The changes of blood test are also considerable.'}], 'secondaryOutcomes': [{'measure': '1-year survival rates', 'timeFrame': 'up to 12 months after the procedures'}, {'measure': 'complication rate', 'timeFrame': 'During the procedure or up to 12 months after the ablation procedure', 'description': 'the frequency of adverse events，including early and late complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['irreversible electroporation', 'ablation', 'neoplasms', 'cancer', 'carcinoma', 'NanoKnife', 'Ablation Techniques'], 'conditions': ['Neoplasms', 'Carcinoma']}, 'descriptionModule': {'briefSummary': 'Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that uses a series of short but intense electric pulses delivered by NanoKnife generator through paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis through irreversibly disrupting cellular membrane integrity. This study aimed to investigate the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE） in the treatment of patients with locally advanced tumors in different anatomical position.', 'detailedDescription': 'This study is a multicenter, open-label trial that aimed to evaluate the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE）in the treatment of patients with locally advanced tumors. Investigators will screen eligible patients and examine them by imaging tests as well as serological examination before and after the IRE procedures to assess the result with the size，blood supply，metabolism of tumors，the change of blood test and treatment-related complications. Big bore multislice spiral CT with thickness 5 cm, 120kilovolt，and 250milliampere，ECG-gated device and anesthesia monitoring equipment were selected during these procedures. Imaging (performed by contrast enhanced CT scan) and serological follow-up was at postoperative day 3 and 1，3，6，12months. The primary endpoint is the effective rate of IRE，and the secondary endpoint is 1-year survival rate and the frequency of adverse events. The response of irreversible electroporation ablation will be assessed according to the different evaluation criterions based on Response Evaluation Criteria in Solid Tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed locally advanced solid tumor.\n2. Unresectable tumors or the patient refused surgical therapy.\n3. Patients in good health conditions can receive general anesthesia.\n4. Patients with good compliance can cooperate with doctors for related tests and the regular follow-up.\n\nExclusion Criteria:\n\n1. Targeted tissues that metallic wallstents or metallics were implanted.\n2. With heart pacemaker or be allergic to contrast medium that can not have related imaging examinations.\n3. With bleeding and psychiatric disorders.\n4. Severe arrhythmia.'}, 'identificationModule': {'nctId': 'NCT02567734', 'briefTitle': 'Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors：The Safety and Efficacy Assessment', 'orgStudyIdInfo': {'id': 'CHN-PLAGH-YY-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irreversible electroporation', 'description': 'In this group，eligible patients were selected to receive the CT-guided percutaneous irreversible electroporation ablation.', 'interventionNames': ['Procedure: CT-guided percutaneous irreversible electroporation']}], 'interventions': [{'name': 'CT-guided percutaneous irreversible electroporation', 'type': 'PROCEDURE', 'otherNames': ['NanoKnife'], 'description': 'Patients undergo the irreversible electroporation ablation that induce protracted cell death by apoptosis through cell membrane perforation.All these procedures will be performed under the guide of Big bore multislice spiral CT scanning system.', 'armGroupLabels': ['Irreversible electroporation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': 'The Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yueyong Xiao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yueyong Xiao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of the Department', 'investigatorFullName': 'Yueyong Xiao', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}