Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT05942118
Status:
RECRUITING
Last Update Posted:
2025-05-20
First Post:
2023-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 262}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2023-06-23', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free-surgical margins', 'timeFrame': '3 years', 'description': 'Number of surgical procedures in which surgical margins are disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).'}], 'secondaryOutcomes': [{'measure': 'Excess breast resection', 'timeFrame': '3 years', 'description': 'Excess breast resection calculated by the "calculated resection ratio" (CRR) as follow: CRR = total resection volume/optimal resection volume'}, {'measure': 'Surgery Time', 'timeFrame': '3 years', 'description': 'Surgery duration (hours)'}, {'measure': 'Hospitalization days', 'timeFrame': '3 years', 'description': "Number of hospitalization's days"}, {'measure': 'Complications', 'timeFrame': '3 years', 'description': 'Complications occurred after biopsy or surgery'}, {'measure': 'Reintervention', 'timeFrame': '3 years', 'description': 'Reintervention rates'}, {'measure': 'Cost-effectiveness analysis', 'timeFrame': '3 years', 'description': 'Cost-effectiveness analysis in different subgroups'}, {'measure': 'Follow up', 'timeFrame': '5 years after enrollment', 'description': '5-years follow-up outcomes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-palpable breast lesion'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions\' localization, with more modern techniques. Scientific evidence supports the efficacy of the new "wire-free" techniques, which appear to be comparable to the WGL in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. There is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. In particular, no randomized trials of comparison between ROLL and magnetic seed localization are currently available. The aim of this randomized study is to compare ROLL with magnetic seed to assess their efficacy for non-palpable breast lesions\' localization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients with non-palpable lesions candidated for surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female;\n* Non-palpable breast lesions;\n* Indication to lesion's surgical excision (lumpectomy, quadrantectomy)\n* Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5);\n* Written informed consent.\n\nExclusion Criteria:\n\n* Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle aspiration (C2);\n* Clinically palpable breast lesion;\n* Breast lesion localization for planned neoadjuvant chemotherapy."}, 'identificationModule': {'nctId': 'NCT05942118', 'acronym': 'SEED02', 'briefTitle': 'Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.', 'organization': {'class': 'OTHER', 'fullName': 'Istituti Clinici Scientifici Maugeri SpA'}, 'officialTitle': 'A Monocentric, Prospective, Randomized Clinical Study Comparing ROLL (Radioguided Occult Lesion Localization) With Magnetic Markers for Preoperative Localization of Non-palpable Breast Lesions in Patients Undergoing Breast Conservative Surgery.', 'orgStudyIdInfo': {'id': '2778'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ROLL', 'description': 'Prior to surgery, an ultrasound-guided localization will be performed and albumin marked with Technetium 99m will be injected close to the tumor and in the subareolar area. During surgery, a specific probe will be used to locate the lesion and sentinel lymph node.', 'interventionNames': ['Procedure: Breast conservative surgery']}, {'label': 'SEED', 'description': 'During diagnostic biopsy or prior to surgery, a magnetic clip will be placed in the breast lesion; during surgery, localization will be performed using a specific probe, while sentinel lymph node localisation, when needed, will be performed even with indocyanine green dye (ICG) or methylene blue dye', 'interventionNames': ['Procedure: Breast conservative surgery']}], 'interventions': [{'name': 'Breast conservative surgery', 'type': 'PROCEDURE', 'description': "Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization", 'armGroupLabels': ['ROLL', 'SEED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Corsi, Professor', 'role': 'CONTACT', 'email': 'fabio.corsi@icsmaugeri.it', 'phone': '0382592272'}, {'name': 'Sara Albasini, MsC', 'role': 'CONTACT', 'email': 'sara.albasini@icsmaugeri.it', 'phone': '3497378405'}], 'facility': 'Istituti Clinici Scientifici Maugeri SpA', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fabio Corsi', 'investigatorAffiliation': 'Istituti Clinici Scientifici Maugeri SpA'}}}}