Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT02432118
Status:
WITHDRAWN
Last Update Posted:
2017-02-02
First Post:
2015-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015412', 'term': 'Mastectomy, Segmental'}, {'id': 'D057233', 'term': 'Radio Frequency Identification Device'}], 'ancestors': [{'id': 'D008408', 'term': 'Mastectomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D010355', 'term': 'Patient Identification Systems'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Insufficient resources', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2015-04-28', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast", 'timeFrame': 'At time of surgery', 'description': 'Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.'}], 'secondaryOutcomes': [{'measure': 'Feedback solicited from the radiologist and surgeon', 'timeFrame': 'Up to 12 months after lumpectomy', 'description': 'Feedback solicited from the radiologist and surgeon will be summarized using qualitative methods. Each questionnaire will be reviewed for both positive and negative responses and summarized.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Neoplasm']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast.\n\nSECONDARY OBJECTIVES:\n\nI. To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system.\n\nOUTLINE:\n\nPatients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have had stereotactic or ultrasound-guided biopsy with marker placement\n* Have a lesion or biopsy marker that is visible under ultrasound\n* Have a surgical target =\\< 6 cm from the skin when lying supine\n* Have a discreet surgical target\n* Have a lesion in which the center/focal area is defined\n* Have the ability to understand and the willingness to sign a written informed consent document\n* Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Require more than one localization needle for localization of the surgical target (bracket localization)\n* Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast\n* Have a prosthesis/implant in the operative breast\n* Have a cardiac pacemaker or defibrillator device\n* Be contraindicated for surgery\n* Be pregnant'}, 'identificationModule': {'nctId': 'NCT02432118', 'briefTitle': 'Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions', 'orgStudyIdInfo': {'id': 'BRS0053'}, 'secondaryIdInfos': [{'id': 'NCI-2015-00630', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '348'}, {'id': 'BRS0053', 'type': 'OTHER', 'domain': 'Stanford University Hospitals and Clinics'}, {'id': 'P30CA124435', 'link': 'https://reporter.nih.gov/quickSearch/P30CA124435', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (radiofrequency-guided localization)', 'description': 'Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.', 'interventionNames': ['Procedure: Lumpectomy', 'Other: Questionnaire Administration', 'Procedure: Radiofrequency-Guided Localization']}], 'interventions': [{'name': 'Lumpectomy', 'type': 'PROCEDURE', 'otherNames': ['Lumpectomy of Breast', 'partial mastectomy'], 'description': 'Undergo lumpectomy', 'armGroupLabels': ['Diagnostic (radiofrequency-guided localization)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Diagnostic (radiofrequency-guided localization)']}, {'name': 'Radiofrequency-Guided Localization', 'type': 'PROCEDURE', 'description': 'Undergo radiofrequency-guided localization', 'armGroupLabels': ['Diagnostic (radiofrequency-guided localization)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jafi Lipson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University Hospitals and Clinics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}