Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT06288620
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer
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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 77}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-25', 'studyFirstSubmitDate': '2024-02-25', 'studyFirstSubmitQcDate': '2024-02-25', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete ablation rate', 'timeFrame': '1 day', 'description': 'The proportion of patients with complete ablation was calculated for all patients. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining.'}], 'secondaryOutcomes': [{'measure': 'Safety of microwave ablation', 'timeFrame': '10 days', 'description': 'Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ablation'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. female patients aged 18-70 years;\n2. patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy;\n3. the tumor smaller than 2cm in greatest diameter confirmed by US (ultrasonography), breast X-ray and breast MRI (contrast-enhanced magnetic resonance image ) were performed at the same time, and the difference of the largest diameter between breast US and MRI was less than 0.5 cm;\n4. the single tumor without other suspicious lesions (BI-RADS (the Breast Imaging Recording and Data System) score ≥4) evaluated by breast US, X-ray and MRI;\n5. the tumor without adhesion to chest wall, nipple or skin;\n6. patients without distant metastasis;\n7. Karnofsky performance status greater than 70%.\n\nExclusion Criteria:\n\n1. multicentric or multifocal breast tumor;\n2. the tumor located on nipple and areola area;\n3. signs of extensive intraductal carcinoma on imaging examination (diffuse malignant calcification on breast X-ray or segmental distribution, non-mass enhancement, ductal or linear enhancement \\> 2.5 cm on MRI);\n4. extensive intraductal component in invasive cancer (more than 50% of the tumor volume) confirmed by pathology;\n5. invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing adenosis;\n6. patients who were pregnant or breastfeeding;\n7. patients with evidence of coagulopathy, chronic liver diseases or renal failure;\n8. patients with previous treatment including chemotherapy, targeted drug therapy, or local radiation therapy, etc;\n9. patients with substance abuse, or mental or psychological disorders that may interfere with study compliance;\n10. any condition that is unstable or likely to compromise the patient's safety and compliance;\n11. patients enrolled in other clinical trials;\n12. diseases or symptoms that other investigators consider unsuitable for participation."}, 'identificationModule': {'nctId': 'NCT06288620', 'briefTitle': 'Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Prospective, Open-label, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer', 'orgStudyIdInfo': {'id': 'MA-EBC-II-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microwave Ablation', 'description': 'Preoperative US-guided microwave ablation of breast cancer', 'interventionNames': ['Procedure: Microwave Ablation']}], 'interventions': [{'name': 'Microwave Ablation', 'type': 'PROCEDURE', 'description': 'Preoperative US-guided microwave ablation of breast cancer', 'armGroupLabels': ['Microwave Ablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenbin Zhou, Professor', 'role': 'CONTACT'}], 'facility': 'the First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Wenbin Zhou,, Professor', 'role': 'CONTACT', 'email': 'zhouwenbin@njmu.edu.cn', 'phone': '025-68308162'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Available from the corresponding author upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}