Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-28 @ 6:17 PM
Study NCT ID:
NCT06799858
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2025-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypotesis 1', 'timeFrame': '1 year', 'description': 'Localization of non-palpable breast tumors and pathological lymph nodes with a magnetic seed Sirius Pintuition is comparable to other localization methods (iodine seed, wire-guided localisation) in the incidence of complications during intraoperative marker detection (absolute and relative incidence; %).'}, {'measure': 'Hypotesis 1_1', 'timeFrame': '1 year', 'description': 'Localization of non-palpable breast tumors and pathological lymph nodes with a magnetic seed Sirius Pintuition is comparable to other localization methods (iodine seed, wire-guided localisation) in the incidence of complications during marker insertion (absolute and relative incidence; %).'}, {'measure': 'Hypotesis 1_2', 'timeFrame': '1 year', 'description': 'Localization of non-palpable breast tumors and pathological lymph nodes with a magnetic seed Sirius Pintuition is comparable to other localization methods (iodine seed, wire-guided localisation) in the incidence seed migration (absolute and relative incidence, %).'}], 'secondaryOutcomes': [{'measure': 'Hypotesis 2', 'timeFrame': '1 year', 'description': 'Localization of non-palpable breast tumors with a magnetic seed Sirius Pintuition is more accurate in terms of more frequent achievement of R0 resection while preserving the oncological radicality (absolute and relative incidence; %).'}, {'measure': 'Hypotesis 2_1', 'timeFrame': '1 year', 'description': 'Localization of non-palpable breast tumors with a magnetic seed Sirius Pintuition is more accurate in removing smaller tissue volume while preserving the oncological radicality (volume, cm3).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Breast Cancer Surgery']}, 'descriptionModule': {'briefSummary': 'A prospective pilot study in the Czech Republic examining the use of magnetic seed Sirius Pintuition for the localization of non-palpable malignant breast tumors and pathological lymph nodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-palpable breast cancer or pathological lymph node localised by magnetic seed Sirius Pintuition.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast cancer confirmed by a core-cut biopsy\n* localisation of non-palpable breast cancer or pathological lymph node with a magnetic seed Sirius Pintuition\n* breast cancer surgery in Surgical dpt, Silesian Hospital in Opava\n\nExclusion Criteria:\n\n* disagree with participation in the study'}, 'identificationModule': {'nctId': 'NCT06799858', 'briefTitle': 'Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed', 'organization': {'class': 'OTHER', 'fullName': 'Silesian Hospital in Opava'}, 'officialTitle': 'Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed: a Pilot Study in the Czech Republic', 'orgStudyIdInfo': {'id': 'EK SNO 429/2024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Breast cancer localisation with magnetic seed Sirius Pintuition', 'type': 'DEVICE', 'description': 'Patients with histologically proven non-palpable breast cancer or with histologically proven pathological lymph node will be localised by a magnetic seed Sirius Pintuition.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '74601', 'city': 'Opava', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jan Žatecký', 'role': 'CONTACT', 'email': 'janzatecky.jz@gmail.com', 'phone': '+420553766111'}], 'facility': 'Silesian Hospital in Opava', 'geoPoint': {'lat': 49.93866, 'lon': 17.90257}}], 'centralContacts': [{'name': 'Jan Žatecký', 'role': 'CONTACT', 'email': 'janzatecky.jz@gmail.com', 'phone': '+420553766111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jan Žatecký', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Jan Žatecký, MD, PhD, Principal Investigator', 'investigatorFullName': 'Jan Žatecký', 'investigatorAffiliation': 'Silesian Hospital in Opava'}}}}