Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT07263451
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of IRE for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'To explore whether the irreversible electroporation can achieve the efficacy and feasibility of breast cancer.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete ablation rate', 'timeFrame': '1 month', 'description': 'Pathologically confirmed absence of viable tumor cells in the resected tumor bed and margins of the post-IRE surgery specimen.'}, {'measure': 'Technical success rate', 'timeFrame': '1 month', 'description': 'The technical success rate of IRE ablation followed by surgery in treating breast cancer'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '1 month', 'description': 'The incidence and severity of all adverse events (AE) and serious adverse events (SAE)'}, {'measure': 'Pain scores', 'timeFrame': '1 month', 'description': 'Pain scores of IRE ablation. The pain intensity was assessed using the 0-10 numerical rating scale (NRS), where 0 indicates no pain and 10 indicates the most severe pain.'}, {'measure': 'Imaging analysis', 'timeFrame': '1 month', 'description': 'the ablation lesion of the imaging results of the ablation lesion after IRE.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'IRE', 'Irreversible Electroporation'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36723911', 'type': 'BACKGROUND', 'citation': 'Zhang K, Teoh J, Laguna P, Dominguez-Escrig J, Barret E, Ramon-Borja JC, Muir G, Bohr J, de Reijke TM, Pelechano Gomez P, Ng CF, Sanchez-Salas R, de la Rosette J. Effect of Focal vs Extended Irreversible Electroporation for the Ablation of Localized Low- or Intermediate-Risk Prostate Cancer on Early Oncological Control: A Randomized Clinical Trial. JAMA Surg. 2023 Apr 1;158(4):343-349. doi: 10.1001/jamasurg.2022.7516.'}, {'pmid': '27495906', 'type': 'BACKGROUND', 'citation': 'Li S, Chen F, Shen L, Zeng Q, Wu P. Percutaneous irreversible electroporation for breast tissue and breast cancer: safety, feasibility, skin effects and radiologic-pathologic correlation in an animal study. J Transl Med. 2016 Aug 5;14(1):238. doi: 10.1186/s12967-016-0993-7.'}, {'pmid': '20191380', 'type': 'BACKGROUND', 'citation': 'Neal RE 2nd, Singh R, Hatcher HC, Kock ND, Torti SV, Davalos RV. Treatment of breast cancer through the application of irreversible electroporation using a novel minimally invasive single needle electrode. Breast Cancer Res Treat. 2010 Aug;123(1):295-301. doi: 10.1007/s10549-010-0803-5. Epub 2010 Feb 27.'}, {'pmid': '19757056', 'type': 'BACKGROUND', 'citation': 'Neal RE 2nd, Davalos RV. The feasibility of irreversible electroporation for the treatment of breast cancer and other heterogeneous systems. Ann Biomed Eng. 2009 Dec;37(12):2615-25. doi: 10.1007/s10439-009-9796-9. Epub 2009 Sep 15.'}, {'pmid': '31161973', 'type': 'BACKGROUND', 'citation': 'Collettini F, Enders J, Stephan C, Fischer T, Baur ADJ, Penzkofer T, Busch J, Hamm B, Gebauer B. Image-guided Irreversible Electroporation of Localized Prostate Cancer: Functional and Oncologic Outcomes. Radiology. 2019 Jul;292(1):250-257. doi: 10.1148/radiol.2019181987. Epub 2019 Jun 4.'}, {'pmid': '35793110', 'type': 'BACKGROUND', 'citation': 'Wang H, Xue W, Yan W, Yin L, Dong B, He B, Yu Y, Shi W, Zhou Z, Lin H, Zhou Y, Wang Y, Shi Z, Ren S, Gao X, Wang L, Xu C. Extended Focal Ablation of Localized Prostate Cancer With High-Frequency Irreversible Electroporation: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Aug 1;157(8):693-700. doi: 10.1001/jamasurg.2022.2230.'}, {'pmid': '31687922', 'type': 'BACKGROUND', 'citation': 'Ruarus AH, Vroomen LGPH, Geboers B, van Veldhuisen E, Puijk RS, Nieuwenhuizen S, Besselink MG, Zonderhuis BM, Kazemier G, de Gruijl TD, van Lienden KP, de Vries JJJ, Scheffer HJ, Meijerink MR. Percutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicenter, Prospective, Single-Arm, Phase II Study. Radiology. 2020 Jan;294(1):212-220. doi: 10.1148/radiol.2019191109. Epub 2019 Nov 5.'}, {'pmid': '25787829', 'type': 'BACKGROUND', 'citation': 'Al Efishat M, Wolfgang CL, Weiss MJ. Stage III pancreatic cancer and the role of irreversible electroporation. BMJ. 2015 Mar 18;350:h521. doi: 10.1136/bmj.h521.'}, {'pmid': '36634919', 'type': 'BACKGROUND', 'citation': 'Shankara Narayanan JS, Hayashi T, Erdem S, McArdle S, Tiriac H, Ray P, Pu M, Mikulski Z, Miller A, Messer K, Carson D, Schoenberger S, White RR. Treatment of pancreatic cancer with irreversible electroporation and intratumoral CD40 antibody stimulates systemic immune responses that inhibit liver metastasis in an orthotopic model. J Immunother Cancer. 2023 Jan;11(1):e006133. doi: 10.1136/jitc-2022-006133.'}, {'pmid': '38513683', 'type': 'BACKGROUND', 'citation': 'Timmer FEF, Geboers B, Ruarus AH, Vroomen LGPH, Schouten EAC, van der Lei S, Vos DJW, Dijkstra M, Schulz HH, Bakker J, van den Bemd BAT, van den Tol PM, Puijk RS, Lissenberg-Witte BI, de Gruijl TD, de Vries JJJ, Lagerwaard FJ, Scheffer HJ, Bruynzeel AME, Meijerink MR. MRI-guided stereotactic ablative body radiotherapy versus CT-guided percutaneous irreversible electroporation for locally advanced pancreatic cancer (CROSSFIRE): a single-centre, open-label, randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2024 May;9(5):448-459. doi: 10.1016/S2468-1253(24)00017-7. Epub 2024 Mar 19.'}, {'pmid': '28799842', 'type': 'BACKGROUND', 'citation': 'Distelmaier M, Barabasch A, Heil P, Kraemer NA, Isfort P, Keil S, Kuhl CK, Bruners P. Midterm Safety and Efficacy of Irreversible Electroporation of Malignant Liver Tumors Located Close to Major Portal or Hepatic Veins. Radiology. 2017 Dec;285(3):1023-1031. doi: 10.1148/radiol.2017161561. Epub 2017 Aug 11.'}, {'pmid': '28453431', 'type': 'BACKGROUND', 'citation': "Sutter O, Calvo J, N'Kontchou G, Nault JC, Ourabia R, Nahon P, Ganne-Carrie N, Bourcier V, Zentar N, Bouhafs F, Sellier N, Diallo A, Seror O. Safety and Efficacy of Irreversible Electroporation for the Treatment of Hepatocellular Carcinoma Not Amenable to Thermal Ablation Techniques: A Retrospective Single-Center Case Series. Radiology. 2017 Sep;284(3):877-886. doi: 10.1148/radiol.2017161413. Epub 2017 Apr 28."}, {'pmid': '29031662', 'type': 'BACKGROUND', 'citation': 'Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.'}, {'pmid': '38417440', 'type': 'BACKGROUND', 'citation': 'Pan H, Yu M, Tang X, Mao X, Liu M, Zhang K, Qian C, Wang J, Xie H, Qiu W, Ding Q, Wang S, Zhou W. Preoperative single-dose camrelizumab and/or microwave ablation in women with early-stage breast cancer: A window-of-opportunity trial. Med. 2024 Apr 12;5(4):291-310.e5. doi: 10.1016/j.medj.2024.01.015. Epub 2024 Feb 27.'}, {'pmid': '32208094', 'type': 'BACKGROUND', 'citation': 'Geboers B, Scheffer HJ, Graybill PM, Ruarus AH, Nieuwenhuizen S, Puijk RS, van den Tol PM, Davalos RV, Rubinsky B, de Gruijl TD, Miklavcic D, Meijerink MR. High-Voltage Electrical Pulses in Oncology: Irreversible Electroporation, Electrochemotherapy, Gene Electrotransfer, Electrofusion, and Electroimmunotherapy. Radiology. 2020 May;295(2):254-272. doi: 10.1148/radiol.2020192190. Epub 2020 Mar 24.'}, {'pmid': '33724066', 'type': 'BACKGROUND', 'citation': 'Meijerink MR, Ruarus AH, Vroomen LGPH, Puijk RS, Geboers B, Nieuwenhuizen S, van den Bemd BAT, Nielsen K, de Vries JJJ, van Lienden KP, Lissenberg-Witte BI, van den Tol MP, Scheffer HJ. Irreversible Electroporation to Treat Unresectable Colorectal Liver Metastases (COLDFIRE-2): A Phase II, Two-Center, Single-Arm Clinical Trial. Radiology. 2021 May;299(2):470-480. doi: 10.1148/radiol.2021203089. Epub 2021 Mar 16.'}, {'pmid': '33117685', 'type': 'BACKGROUND', 'citation': 'Yu J, Han ZY, Li T, Feng WZ, Yu XL, Luo YC, Wu H, Jiang J, Wang JD, Liang P. Microwave Ablation Versus Nipple Sparing Mastectomy for Breast Cancer </=5 cm: A Pilot Cohort Study. Front Oncol. 2020 Oct 7;10:546883. doi: 10.3389/fonc.2020.546883. eCollection 2020.'}, {'pmid': '32356159', 'type': 'BACKGROUND', 'citation': 'Yang Q, Li H, Chen BH, He GZ, Wu XP, Wang LX, Wu H, Dou JP, Han ZY, Zhang J, Yu XL, Yu J, Liang P. Ultrasound-guided percutaneous microwave ablation for 755 benign breast lesions: a prospective multicenter study. Eur Radiol. 2020 Sep;30(9):5029-5038. doi: 10.1007/s00330-020-06868-9. Epub 2020 Apr 30.'}, {'pmid': '28050693', 'type': 'BACKGROUND', 'citation': 'Mauri G, Sconfienza LM, Pescatori LC, Fedeli MP, Ali M, Di Leo G, Sardanelli F. Technical success, technique efficacy and complications of minimally-invasive imaging-guided percutaneous ablation procedures of breast cancer: A systematic review and meta-analysis. Eur Radiol. 2017 Aug;27(8):3199-3210. doi: 10.1007/s00330-016-4668-9. Epub 2017 Jan 3.'}, {'pmid': '24561446', 'type': 'BACKGROUND', 'citation': 'Chu KF, Dupuy DE. Thermal ablation of tumours: biological mechanisms and advances in therapy. Nat Rev Cancer. 2014 Mar;14(3):199-208. doi: 10.1038/nrc3672.'}, {'pmid': '32203697', 'type': 'BACKGROUND', 'citation': 'Benson JR. Quality of life after breast-conserving surgery for women with non-low-risk ductal carcinoma in situ. Lancet Oncol. 2020 May;21(5):612-614. doi: 10.1016/S1470-2045(20)30135-2. Epub 2020 Mar 20. No abstract available.'}, {'pmid': '33433946', 'type': 'BACKGROUND', 'citation': 'Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.'}, {'pmid': '31813636', 'type': 'BACKGROUND', 'citation': 'Vicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial. Lancet. 2019 Dec 14;394(10215):2155-2164. doi: 10.1016/S0140-6736(19)32514-0. Epub 2019 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer.', 'detailedDescription': 'This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer. Qualified patients will receive IRE ablation, followed by standard surgical resection. The efficacy and feasibility of IRE will be evaluated through statistical analysis of the outcomes, which will be recorded in accordance with the primary and secondary efficacy endpoints.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female, aged 18 years or older.\n2. Medically fit for both surgery and general anesthesia, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n3. Treatment-naïve, primary, unifocal breast cancer with a maximum diameter of ≤ 2.0 cm as assessed by MRI.\n4. Pathologically confirmed diagnosis of Invasive Ductal Carcinoma (IDC) within 3 months prior to enrollment.\n5. Tumor that presents as a well-defined, localized mass and is clearly visualized on both breast ultrasound (for intraoperative guidance) and breast DCE-MRI (for baseline measurement and treatment planning).\n6. The subject must be able to understand the purpose of the trial, voluntarily participate, and provide written informed consent.\n\nExclusion Criteria:\n\n1. Known coagulopathy or bleeding diathesis (defined as a platelet count \\< 50×10⁹/L or an International Normalized Ratio (INR) \\> 1.5).\n2. Presence of an implanted cardiac pacemaker, defibrillator, or any other active electronic medical device.\n3. History of significant cardiac disease, including but not limited to: uncontrolled cardiac arrhythmias or congestive heart failure classified as New York Heart Association (NYHA) Class III or IV.\n4. Patients who are pregnant, lactating, or planning a pregnancy during the study period.\n5. Known severe allergy or anaphylactic reaction to MRI contrast agents.\n6. Known high-risk genetic susceptibility to breast cancer (e.g., BRCA1/2 mutation carrier) associated with an increased risk of ipsilateral breast tumor recurrence following ablation.\n7. Presence of distant metastases.\n8. Any other medical or psychiatric condition that, in the investigator's judgment, would compromise the patient's safety or compliance with the study protocol."}, 'identificationModule': {'nctId': 'NCT07263451', 'briefTitle': 'Safety and Feasibility of IRE for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Safety and Feasibility of Irreversible Electroporation for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study', 'orgStudyIdInfo': {'id': 'IREBreast'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IRE and Surgical Resection', 'description': 'Qualified patients will receive IRE ablation, followed by standard surgical resection for breast cancer. The efficacy and feasibility of IRE will be evaluated through statistical analysis of the outcomes, which will be recorded in accordance with the primary and secondary efficacy endpoints.', 'interventionNames': ['Device: IRE by stunning pulse therapy device']}], 'interventions': [{'name': 'IRE by stunning pulse therapy device', 'type': 'DEVICE', 'description': 'Qualified patients will receive IRE ablation, followed by standard surgical resection for breast cancer.During the process, patients will be followed up and evaluated', 'armGroupLabels': ['IRE and Surgical Resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': "Tian'an Jiang, PhD", 'role': 'CONTACT', 'email': 'tiananjiang@126.com', 'phone': '0571-87236516'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang', 'role': 'CONTACT', 'email': 'tiananjiang@zju.edu.cn', 'phone': '18857127666'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': "Tian'an Jiang, PhD", 'role': 'CONTACT', 'email': 'tiananjiang@zju.edu.cn', 'phone': '0571-87236516'}], 'overallOfficials': [{'name': "Tian'an Jiang, PhD", 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang University'}, {'name': 'Peifen Fu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Tian'an Jiang", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': "Tian'an Jiang", 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}