Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:37 PM
Study NCT ID:
NCT07441733
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The golden standard for obtaining the sentinel lymph node (SLN) in patients with breast cancer currently is radio guided surgery with radioisotope technetium (99mTc). However, the use of 99mTc-nanocolloid presents logistical challenges and contributes to patient burden. A proven effective and safe alternative is fluorescence imaging using indocyanine green (ICG).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'measure the percentage of sentinel lymph nodes identified by the 99mTc nanocolloid or the ICG fluorescent signal (%)'}], 'secondaryOutcomes': [{'measure': 'Percentage of SLNs that has 99mTc uptake/ is fluorescent', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Percentage of sentinel lymph nodes that have an absorption of 99mTc and are fluorescent (%)'}, {'measure': 'Detection time', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Detection time is defined as time between skin incision and SLN resection in minutes (min)'}, {'measure': 'Total operative time', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Registration of the duration of the total surgical procedure including the SN-procedure (min or h)'}, {'measure': 'Number of complications and (serious) adverse events', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'registration of the number of serious adverse events and complications, including seroma, wound infection and bleeding'}, {'measure': 'loco regional recurrence after 1 year follow-up', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of regional loco recurrences assessed through clinical examinations'}, {'measure': 'The pathology of SLNs identified', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of micro and macro metastases and isolated tumor cells (ITCs)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'lymph node', '99mTc', 'ICG'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.', 'detailedDescription': 'Pre-implementation: standard sentinel node procedure using 99mTc-nanocolloid, which implies 99mTc injection the day or the morning before surgery. Transition period: participating surgeons will receive on-site training, proctoring, and ongoing guidance from experienced surgeons and early adopters of the ICG method from St. Antonius Hospital, Utrecht, The Netherlands until they achieve confidence and proficiency in using ICG for SLNB. Post-implementation: 5 mg (2 ml) ICG will be injected periareolar after administration of general anesthesia and before incision. The SLN will be visualized by fluorescent imaging using a fluorescence camera.\n\nMain study endpoints: Primary endpoint is the identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG. Secondary endpoints are total number of LNs removed, detection time, total operative time, complications and (serious) adverse events, loco regional recurrence after 1 year follow-up, pre-implementation expectations regarding ICG, post-implementation experiences regarding ICG including barriers and success factors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically node-negative, DCIS or invasive stage T1-T3 breast cancer confirmed by biopsy\n* Preoperative axillary ultrasound to confirm clinical node-negative status\n* Indication for breast cancer surgery with SLNB via axillar incision\n* Written informed consent according to national regulations\n\nExclusion Criteria:\n\n* Patients \\< 18 years old.\n* Indication for breast cancer surgery with SLNB via mastectomy incision\n* Known allergy for ICG, intravenous contrast or iodine\n* History of axillary lymph node dissection\n* Pregnancy or breast-feeding\n* Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol'}, 'identificationModule': {'nctId': 'NCT07441733', 'acronym': 'INFLUENCE II', 'briefTitle': 'Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Casa di Cura Dott. Pederzoli'}, 'officialTitle': 'INFLUENCE II - a Pilot Study for Implementation Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively FLUorEsceNt Imaging Using indoCyaninE Green: a Pilot Study for Implementation', 'orgStudyIdInfo': {'id': '418CET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '99mTc', 'description': 'radioisotope technetium technique will be used for sentinel lymph node localization(99mTc)', 'interventionNames': ['Procedure: technetium 99 used as a tracer for sentinel lymph node']}, {'type': 'EXPERIMENTAL', 'label': 'ICG', 'description': 'indocyanine green fluorescent imaging technique will be used for sentinel lymph node localization (ICG)', 'interventionNames': ['Procedure: ICG used as a tracer for sentinel lymph node']}], 'interventions': [{'name': 'ICG used as a tracer for sentinel lymph node', 'type': 'PROCEDURE', 'description': 'ICG used as a tracer for sentinel lymph node instead of technetium 99', 'armGroupLabels': ['ICG']}, {'name': 'technetium 99 used as a tracer for sentinel lymph node', 'type': 'PROCEDURE', 'description': 'technetium 99 used as a tracer for sentinel lymph node instead of ICG', 'armGroupLabels': ['99mTc']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peschiera del Garda', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Guerini, MD', 'role': 'CONTACT', 'email': 'urc@ospedalepederzoli.it', 'phone': '+39 0456444193'}], 'facility': 'Ospedale P. Pederzoli Casa di Cura Privata S.p.A.', 'geoPoint': {'lat': 45.43912, 'lon': 10.68614}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa di Cura Dott. Pederzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}