Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-05 @ 6:28 PM
Study NCT ID:
NCT02522468
Status:
COMPLETED
Last Update Posted:
2022-08-10
First Post:
2015-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of RSL Versus WL for Malignant Breast Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-09', 'size': 254282, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-05T12:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-05', 'studyFirstSubmitDate': '2015-07-28', 'studyFirstSubmitQcDate': '2015-08-11', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Resection Margins', 'timeFrame': '30 days', 'description': 'The primary objective for this study will be the comparison between Radioactive Seed Localization (RSL) and Wire-Guided Localization (WL) based on negative margins in malignant breast disease. This is defined as no tumor on ink in invasive disease and greater than or equal to 2mm from the inked margin in non-invasive disease (DCIS).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast- Female']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized trial is to determine the superiority of utilizing radioactive seed localization (RSL) over wire-guided localization (WL) for palpable or non-palpable malignant lesions in patients undergoing breast conservation surgery (BCS).', 'detailedDescription': 'Consented and eligible subjects will be randomized to either radioactive seed localization or wire localization and stratified by surgeon and invasive versus DCIS prior to localization. Subjects on both arms will undergo breast conservation surgery including surgical specimen removal. Specimens will be grossed according to standard of care procedures. Localization, breast conservation surgery, and post-operative appointments will follow standard of care guidelines. Surveys will be administered according to the study calendar to the radiologist, surgeon, pathologist, and subject for data collection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 20 to 99 years of age\n* Breast lesion necessitating image-guided excision\n* Unifocal disease\n* Breast-conservation candidate\n* Biopsy-proven malignant breast lesion including by not limited to invasive ductal carcinoma, invasive lobular carcinoma, and ductal carcinoma in situ\n* Signed written informed consent document by the subject and/or a LAR\n\nExclusion Criteria:\n\n* Male\n* Multifocal or multicentric disease\n* Receiving neoadjuvant chemotherapy\n* Pregnant or breastfeeding\n* Locally advanced disease\n* Breast conservation contraindication such as inability to receive whole breast radiation therapy, inability to tolerate localization procedure, inability to lay flat or prone for radiation, and undesirable tumor to breast ratio\n* Prior breast cancer on ipsilateral side\n* Unable or unwilling to adhere to post-localization instructions (e.g. timely seed removal)'}, 'identificationModule': {'nctId': 'NCT02522468', 'acronym': 'BCS-RSL-001', 'briefTitle': 'A Trial of RSL Versus WL for Malignant Breast Disease', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Randomized Single-Center Superiority Trial of Radioactive Seed Localization Versus Needle Localization for Malignant Breast Disease.', 'orgStudyIdInfo': {'id': 'LCI-BRE-BCS-RSL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radioactive Seed Localization', 'description': 'Radioactive Seeds', 'interventionNames': ['Procedure: Radioactive Seed Localization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wire Localization', 'description': 'Wire', 'interventionNames': ['Procedure: Wire Localization']}], 'interventions': [{'name': 'Radioactive Seed Localization', 'type': 'PROCEDURE', 'armGroupLabels': ['Radioactive Seed Localization']}, {'name': 'Wire Localization', 'type': 'PROCEDURE', 'armGroupLabels': ['Wire Localization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Lejla Hadzikadic-Gusic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}