Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-22 @ 11:17 AM
Study NCT ID:
NCT05942092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2023-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion: Comparison Between Techniques.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015412', 'term': 'Mastectomy, Segmental'}], 'ancestors': [{'id': 'D008408', 'term': 'Mastectomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free-surgical margins', 'timeFrame': '6 months', 'description': 'Number of surgical procedures in which surgical margins are tumor disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).'}], 'secondaryOutcomes': [{'measure': 'Excess breast resection', 'timeFrame': '6 months', 'description': 'Excess breast resection calculated by the "calculated resection ratio" (CRR=total resection volume/optimal resection volume)'}, {'measure': 'Surgery time', 'timeFrame': '6 months', 'description': 'Surgery duration'}, {'measure': "Hospitalization's days", 'timeFrame': '6 months', 'description': "Number of hospitalization's days"}, {'measure': 'Complications', 'timeFrame': '6 months', 'description': 'Complications occurred after biopsy or surgery'}, {'measure': 'Reintervention', 'timeFrame': '6 months', 'description': 'Reintervention rates'}, {'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': 'Nowadays, Breast Conservative Surgery (BCS) is the standard of care for patients affected by early breast lesions. Screening programmes led to an increase of impalpable breast lesion detection rates. These patients are often eligible for BCS and an accurate preoperative localization technique for the detection of the lesion is required in order to guarantee a safe surgical excision.\n\nThe primary goal of BCS is to obtain a complete resection of the tumor with disease-free surgical margins. The presence of tumor on surgical margins on postoperative histological examination of the specimen increases the risk of local recurrence and it requires a surgical re-excision. For all these reasons different techniques for localization of occult breast lesions have been developed over time. Since \'70s, the wire guided localization (WGL) technique has represented the gold standard technique; however, it has several limitations such as wire migration or fracture and patient\'s referred discomfort related to wire placement. Other techniques have been proposed such as the ROLL and magnetic seeds.\n\nThe ROLL consists of the injection of a radioactive substance into the breast lesion and the localization during surgery is allowed by using a handheld gamma probe. Limitations of this technique are represented by the need of radioactive injection the day before surgery with subsequent longer hospitalizations and the possible spread of the radioactive substance into breast tissue leading to larger resections.\n\nThe latest technological evolution is represented by magnetic seeds, small devices deployed into the lesion even up to more than 30 days before surgery and identified with a specific magnetic probe during surgery.\n\nCurrently there are several studies of comparison between the WGL and the more modern techniques. All of these data claim the effectiveness of the new "wire-free" methodics ensuring a safe surgical resection with tumor-free margins and, in some cases, a better aesthetic result.\n\nStudies of comparison between the modern techniques are limited. There is no scientific evidence of the superiority of magnetic seeds compared to ROLL.\n\nThe aim of this retrospective study is to compare ROLL with magnetic seed to assess their efficacy in the localization of non-palpable breast lesions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer women with non-palpable lesions', 'genderDescription': 'Breast cancer is gender based', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients between 18 and 85 years who underwent to breast conservative surgery for non-palpable occult breast lesions;\n* Intraoperative localization of breast lesion with ROLL or magnetic seed;\n* Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5).\n\nExclusion Criteria:\n\n* B2 or C2 at preoperative needle breast biopsy or fine needle breast aspiration.\n* Breast tumor localization with clip for neoadjuvant chemotherapy.'}, 'identificationModule': {'nctId': 'NCT05942092', 'acronym': 'SEED01', 'briefTitle': 'ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion: Comparison Between Techniques.', 'organization': {'class': 'OTHER', 'fullName': 'Istituti Clinici Scientifici Maugeri SpA'}, 'officialTitle': 'A Retrospective Multicentric Clinical Study Comparing Radioguided Occult Lesion Localization (ROLL) and Magnetic Seed in the Intraoperative Localization of Non-palpable Breast Lesions During Breast Conservative Surgery.', 'orgStudyIdInfo': {'id': '2755'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ROLL', 'interventionNames': ['Procedure: Breast conserving surgery']}, {'label': 'SEED', 'interventionNames': ['Procedure: Breast conserving surgery']}], 'interventions': [{'name': 'Breast conserving surgery', 'type': 'PROCEDURE', 'description': "Breast conserving surgery after lesion's localization with ROLL or magnetic seed", 'armGroupLabels': ['ROLL', 'SEED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'country': 'Italy', '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'}}}}