Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-31 @ 10:06 AM
Study NCT ID:
NCT01827969
Status:
WITHDRAWN
Last Update Posted:
2025-09-16
First Post:
2012-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2012-11-06', 'studyFirstSubmitQcDate': '2013-04-09', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of ablathermy', 'timeFrame': '2 years', 'description': 'Effectiveness of ablathermy focused ultrasound breast tumors will be assessed based on histological criteria : the intervention will be considered effective for a participant if there is a destruction of the tumor mass by coagulation necrosis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Women', 'breast tumor', 'planned mastectomy'], 'conditions': ['Breast Tumor']}, 'descriptionModule': {'briefSummary': 'The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.', 'detailedDescription': 'The treatment consists of tumor ablation by USF, guided by MRI, performed under local anesthesia and sedation. Patients will be operated (mastectomy) from 48 hours after ablation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive Breast Carcinoma with histologically confirmed hormone receptor analysis, the grade of the tumor, the expression of Her-2.\n* Lesion classified T1-T2-T3 unifocal or multifocal with or without associated microcalcifications\n* Lesion recognizable and identifiable in MRI\n* Indication of mastectomy with or without axillary\n* Lesion located more than 10 mm from the skin, the nipple and pectoralis major\n* No cons-indication to MRI (pacemaker)\n* Women whose age is ≥ 18 years\n* If premenopausal patient: patient contraceptives\n* Patient has signed informed consent\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Tumor-TD T4B classified or non-palpable lesion\n* If age \\<70 years: no indication of adjuvant chemotherapy and neoadjuvant\n* MRI lesions have not been identified, located within 10 mm of the skin and pectoral muscle, greater than 25 mm diameter\n* Inability to hold still in the prone position, arms extended, for 30 minutes\n* Contraindication to MRI\n* Patient deprived of liberty and major subject of a measure of legal protection or unable to consent\n* Patient participating in another interventional clinical trial within 30 days prior to baseline and during the trial.'}, 'identificationModule': {'nctId': 'NCT01827969', 'acronym': 'USF', 'briefTitle': 'Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy', 'orgStudyIdInfo': {'id': 'IB2009-58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ablathermy focused ultrasound', 'description': 'ablathermy focused ultrasound', 'interventionNames': ['Procedure: ablathermy focused ultrasound']}], 'interventions': [{'name': 'ablathermy focused ultrasound', 'type': 'PROCEDURE', 'description': 'ablathermy focused ultrasound', 'armGroupLabels': ['ablathermy focused ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'state': 'Aquitaine', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'PALUSSIERE Jean, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Bergonié'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}