Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-26 @ 2:54 AM
Study NCT ID:
NCT02860104
Status:
UNKNOWN
Last Update Posted:
2016-11-23
First Post:
2016-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-22', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction in volume', 'timeFrame': '5 year', 'description': 'the volume reduction ratio (VRR) which was calculated by the following equation: VRR (%) = \\[(initial volume - final volume) × 100\\]/initial volume.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['microwave ablation', 'breast', 'multicenter'], 'conditions': ['Neoplasm of Breast']}, 'referencesModule': {'references': [{'pmid': '32356159', 'type': 'DERIVED', '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': '31179781', 'type': 'DERIVED', 'citation': 'Yu J, Wu H, Meng XW, Mu MJ, Dou JP, Ahmed M, Liang P. Ultrasound-guided percutaneous microwave ablation of central intraductal papilloma: a prospective pilot study. Int J Hyperthermia. 2019;36(1):606-612. doi: 10.1080/02656736.2019.1619849.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will perform this study to prospectively analyse the clinical outcome after percutaneous microwave ablation(MWA) of benign and malignant breast lesion under ultrasound (US) guidance.', 'detailedDescription': 'A total of more than 500 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in seven centers of China will be recruited in this study and underwent US-guided percutaneous MWA treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be measured and analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast lesion proved by using core-needle biopsy;\n* for benign lesions,lesion 1.0 cm or larger in greatest diameter and continually increasing during a half year follow-up; for malignant ones, lesion size 2cm or smaller;\n* distance of at least 1.0cm to papilla with the patients supine;\n* the symptoms of local pain, discomfortable or compression considered probably relating to the lesion of breast;\n* the patient with evidently psychological pressure due to the occurrence of the lesion;\n* patients unwilling or refused to receive other treatment and presence of an appropriate route for percutaneous puncture under US guidance.\n\nExclusion Criteria:\n\n* patients who were pregnant or breast-feeding;\n* patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction;\n* patients during menstrual period;\n* patients who wanted to undergo other therapies including surgical excision and vacuum-assisted biopsy.'}, 'identificationModule': {'nctId': 'NCT02860104', 'briefTitle': 'Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions: A Prospective Multicenter Study', 'orgStudyIdInfo': {'id': '939530lp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'microwave ablation', 'description': 'microwave ablation', 'interventionNames': ['Device: microwave ablation']}], 'interventions': [{'name': 'microwave ablation', 'type': 'DEVICE', 'description': 'ultrasound guided percutaneous microwave ablation for breast lesions', 'armGroupLabels': ['microwave ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Yu, Doctor', 'role': 'CONTACT', 'email': 'yu-jie301@hotmail.com', 'phone': '8610-66939530'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jie Yu, Doctor', 'role': 'CONTACT', 'email': 'yu-jie301@hotmail.com', 'phone': '8610-66939530'}], 'overallOfficials': [{'name': 'Ping Liang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'cosmetics effect, volume reduction rate,complications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair', 'investigatorFullName': 'Ping Liang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}