Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06339658
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2024-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ICG vs Blue Patent for TAD in cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
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': 'C039418', 'term': 'DAT protocol 1'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of sentinel lymph node between tracers', 'timeFrame': '2 years', 'description': 'Compare the detection rate of sentinel lymph node between ICG and blue patent in cN+ patients after neoadjuvant treatment'}], 'secondaryOutcomes': [{'measure': 'Detection rate of SLNB with ICG versus Tc99', 'timeFrame': '2 years', 'description': 'Compare the detection rate of sentinel lymph node between ICG and Tc99 in cN+ patients after neoadjuvant treatment'}, {'measure': 'Adverse effects', 'timeFrame': '2 years', 'description': 'Evaluate the adverse effects from the use of each of the tracers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Axillary Metastases']}, 'descriptionModule': {'briefSummary': 'To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.', 'detailedDescription': 'This patient registry is designed to prospectively collect standardized clinical, imaging, surgical, and pathological data from patients with cN1 breast carcinoma undergoing targeted axillary dissection (TAD) following neoadjuvant chemotherapy, using indocyanine green (ICG) as a lymphatic tracer.\n\nTo ensure data quality and consistency the following procedures and quality control measures will be implemented:\n\nStandardized Case Report Forms (CRFs):\n\nAll data will be recorded using electronic CRFs developed specifically for the registry. These forms are structured to capture relevant demographic, clinical, radiological, surgical, and pathological variables, including tracer detection rates, number of retrieved nodes, false-negative rates, and complications.\n\nCenter Training and Accreditation:\n\nAll participating surgeons and radiologists will receive training on standardized procedures for TAD using ICG, including injection technique, intraoperative fluorescence detection, and specimen handling. Regular inter-institutional meetings will be held to reinforce protocol adherence.\n\nQuality Assurance in Imaging and Pathology:\n\nLymph node localization procedures (e.g., clip placement, imaging review) and histopathological analyses will follow unified protocols.\n\nEthics and Patient Confidentiality:\n\nAll data will be de-identified and managed in compliance with GDPR and local data protection regulations. Informed consent will be obtained from each participant prior to data inclusion.\n\nFollow-up and Outcome Tracking:\n\nThe registry will track short- and mid-term surgical outcomes, including detection rates, surgical complications, and axillary recurrence, ensuring longitudinal quality assessment of the ICG-guided TAD approach.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer cN+ patients who underwent neadjuvant treatment and will be candidates to perfom a targeted axillay dissection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer cN+ patients who undergo neadjuvant treatment.\n\nExclusion Criteria:\n\n* Patients in whom there is a contraindication for the use of ICG.\n* Patients in whom there is evidence of progression of the disease after neoadjuvant treatment.'}, 'identificationModule': {'nctId': 'NCT06339658', 'briefTitle': 'ICG vs Blue Patent for TAD in cN1 Breast Carcinoma After Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'TAD-ICG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Indocianine Green (ICG)', 'description': 'ICG tracer', 'interventionNames': ['Procedure: Targeted axillary dissection (TAD) by ICG']}, {'label': 'Blue patent', 'description': 'Blue patent tracer', 'interventionNames': ['Procedure: Targeted axillary dissection (TAD) by Blue patent']}], 'interventions': [{'name': 'Targeted axillary dissection (TAD) by ICG', 'type': 'PROCEDURE', 'description': 'Use of ICG during the targeted axillary dissection (TAD)', 'armGroupLabels': ['Indocianine Green (ICG)']}, {'name': 'Targeted axillary dissection (TAD) by Blue patent', 'type': 'PROCEDURE', 'description': 'Use of Blue patent during the targeted axillary dissection (TAD)', 'armGroupLabels': ['Blue patent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Amparo Garcia-Tejedor, MDPhD', 'role': 'CONTACT', 'email': 'agarciat@bellvitgehospital.cat', 'phone': '0034-660223417'}], 'facility': 'Hospital de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'centralContacts': [{'name': 'Amparo Garcia-Tejedor', 'role': 'CONTACT', 'email': 'agarciat@bellvitgehospital.cat', 'phone': '0034-660223417'}], 'overallOfficials': [{'name': 'Carlos Ortega-Expósito', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari de Bellvitge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amparo Garcia-Tejedor', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}