Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT02430766
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2015-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irreversible Electroporation(IRE) For Unresectable Lymph Node Metastases(Close to Nerve)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018274', 'term': 'Electroporation'}], 'ancestors': [{'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2015-04-26', 'studyFirstSubmitQcDate': '2015-04-26', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Adverse events', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'Percentage of lesions that show no sign of recurrence 12 months after IRE', 'timeFrame': '12 months'}, {'measure': 'A minimum and maximum range of voltage for safe and effective IRE', 'timeFrame': '3 months', 'description': 'analyzed for optimal choice.'}, {'measure': 'Progress free disease (PFS)', 'timeFrame': '12 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': '36 months', 'description': 'Patients will be followed for 36 months after IRE for OS analyzed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['irreversible electroporation', 'Unresectable Lymph Node Metastases'], 'conditions': ['Lymph Node Metastases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Lymph Node Metastases.', 'detailedDescription': 'By enrolling patients with unresectable Lymph Node Metastases adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Lymph Node Metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lymph Node Metastases diagnosed by positive biopsy or non-invasive criteria,\n* Not suitable for surgical resection,\n* Eastern Cooperative Oncology Group (ECOG) score of 0-1,\n* A prothrombin time ratio \\> 50%,\n* Platelet count \\> 80x10\\^9/L,\n* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,\n* Able to comprehend and willing to sign the written informed consent form (ICF),\n* Have a life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,\n* Any active implanted device (eg Pacemaker),\n* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,\n* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,\n* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.'}, 'identificationModule': {'nctId': 'NCT02430766', 'acronym': 'IRE', 'briefTitle': 'Irreversible Electroporation(IRE) For Unresectable Lymph Node Metastases(Close to Nerve)', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'Irreversible Electroporation(IRE) For Unresectable Lymph Node Metastases: Phase I and Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'lymphnode metastases-IRE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IRE Group', 'description': 'irreversible electroporation for Unresectable Lymph Node Metastase', 'interventionNames': ['Procedure: Irreversible electroporation (IRE)', 'Device: NanoKnife']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The patients without treatment'}], 'interventions': [{'name': 'Irreversible electroporation (IRE)', 'type': 'PROCEDURE', 'otherNames': ['NanoKnife'], 'description': 'Irreversible Electroportion For Unresectable Lymph Node Metastases guide with ultrasound or/and CT.', 'armGroupLabels': ['IRE Group']}, {'name': 'NanoKnife', 'type': 'DEVICE', 'armGroupLabels': ['IRE Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Biological treatment center in Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Lizhi Niu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuda Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}