Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-01 @ 10:42 AM
Study NCT ID:
NCT03200704
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2017-06-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'colleen.roden@stryker.com', 'phone': '931-267-2041', 'title': 'Colleen Roden, Director of Clinical Sciences and Operations', 'organization': 'Novadaq Technologies ULC, now a part of Stryker'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Collected over the treatment duration period (Day 0) and followed through to Day 30', 'description': 'The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.', 'eventGroups': [{'id': 'EG000', 'title': 'IC2000/SPY-PHI', 'description': 'Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.\n\nIC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer\n\nTc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 27, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Febrile Neutropenia', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina Pectoris', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Goitre', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site discoloration', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile colitis', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Infection', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Nausea', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seroma', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Flap Necrosis', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Secretion', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oxygen Saturation Decreased', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone Pain', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Wall Hematoma', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Occlusion', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Apnea', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic Skin Ulcer', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Discoloration', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Necrosis', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oxygen saturation decreased', 'notes': 'A subject may have reported more than one Adverse Events.\n\n\\*Five serious adverse events, of which one ("Apneic Episode Desaturation") was split into two different terms, \'Oxygen Saturation Decreased\' and \'Apnea\', therefore resulting in six SAEs.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Apnea', 'notes': 'A subject may have reported more than one Adverse Events.\n\n\\*Five serious adverse events, of which one ("Apneic Episode Desaturation") was split into two different terms, \'Oxygen Saturation Decreased\' and \'Apnea\', therefore resulting in six SAEs.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'notes': 'A subject may have reported more than one Adverse Events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}, {'units': 'Lymph Nodes', 'counts': [{'value': '406', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IC2000/SPY-PHI', 'description': 'Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.\n\nIC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer\n\nTc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer'}], 'classes': [{'title': 'Proportion of histology confirmed lymph nodes identified using IC2000 and SPY', 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}]}]}, {'title': 'Proportion of histology confirmed lymph nodes identified using Tc-99m/Gamma Probe', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Hypothesis:\n\nH0: QT ≤ QC - 0.05 H1: QT \\> QC - 0.05', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '90% power, 2.5% one-sided significance level,5% non-inferiority margin'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From Technetium-99 (Tc-99m) injection to the completion of surgery', 'unitOfMeasure': 'Lymph Nodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lymph Nodes', 'denomUnitsSelected': 'Lymph Nodes', 'populationDescription': 'PP and mITT populations'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IC2000/SPY-PHI', 'description': 'Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.\n\nIC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer\n\nTc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer'}], 'classes': [{'title': 'Proportion of Subjects with At Least One Lymph Node Identified by IC2000 and SPY in-vivo', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}, {'title': 'Proportion of Subjects with At Least One Lymph Node Identified by Tc-99m/Gamma Probe', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Technetium-99 (Tc-99m) injection to the completion of surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP and mITT population\n\n\\*The PP and mITT populations were identical'}, {'type': 'SECONDARY', 'title': 'Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}, {'units': 'Lymph Nodes', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IC2000/SPY-PHI', 'description': 'Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.\n\nIC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer\n\nTc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer'}], 'classes': [{'categories': [{'title': 'Proportion of Lymph Nodes Identified by IC2000 and SPY in-vivo With Lymphatic Vessel Mapping', 'measurements': [{'value': '357', 'groupId': 'OG000'}]}, {'title': 'Proportion of Lymph Nodes Identified by IC2000 and SPY in-vivo Without Lymphatic Vessel Mapping', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From Technetium-99 (Tc-99m) injection to the completion of surgery', 'unitOfMeasure': 'Lymph Nodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lymph Nodes', 'denomUnitsSelected': 'Lymph Nodes', 'populationDescription': 'Total number of histology confirmed clinical lymph nodes (specimens) identified and excised by IC2000 and SPY.\n\n\\*The PP and mITT populations were identical'}, {'type': 'SECONDARY', 'title': 'To Assess the Safety of Intradermal Injection of IC2000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IC2000/SPY-PHI', 'description': 'Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.\n\nIC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer\n\nTc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Technetium-99 (Tc-99m) injection to the completion of surgery', 'description': 'Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety cohort (N=151)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IC2000/SPY-PHI', 'description': 'Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.\n\nIC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer\n\nTc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects assessed for eligibility (n=153)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'IC2000/SPY-PHI', 'description': 'Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.\n\nIC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer\n\nTc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.2', 'spread': '11.50', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '\\*PP/ mITT population (N=148)'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '\\*PP/ mITT population (N=148)'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '120', 'groupId': 'BG000'}]}, {'title': 'Black or African', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '\\*PP/ mITT population (N=148)'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '\\*Please note, the region of enrollment total reflects total subjects enrolled (N=152)'}, {'title': 'Smoker, n (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Current', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Past', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Never', 'measurements': [{'value': '98', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '\\*PP/ mITT population (N=148)'}, {'title': 'Alcohol consumption, n (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '\\*PP/ mITT population (N=148)'}, {'title': 'Comorbid conditions of interest, n (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hypertension', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Cardiac Disease', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'COPD', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Diabetes', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Renal Failure', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Liver Disease', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '\\*PP/ mITT population (N=148)'}], 'populationDescription': 'Total enrollment (N=152)\n\n\\*PP and mITT population (N=148)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-13', 'size': 11228972, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-27T12:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, open label, within patient study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'dispFirstSubmitDate': '2021-08-13', 'completionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2017-06-22', 'resultsFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2017-06-23', 'dispFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-30', 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe', 'timeFrame': 'From Technetium-99 (Tc-99m) injection to the completion of surgery'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe', 'timeFrame': 'From Technetium-99 (Tc-99m) injection to the completion of surgery'}, {'measure': 'Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI', 'timeFrame': 'From Technetium-99 (Tc-99m) injection to the completion of surgery'}, {'measure': 'To Assess the Safety of Intradermal Injection of IC2000', 'timeFrame': 'From Technetium-99 (Tc-99m) injection to the completion of surgery', 'description': 'Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Lymph Node Mapping', 'Sentinel Lymph Node Biopsy']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures as confirmed by Technitium99m (Tc99m) and Gamma Probe.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Be 18 years of age or older\n2. Subjects with American Cancer Society Clinical Stage 0 Ductal Carcinoma in Situ (DCIS) (Stage 0, Tis, N0, M0), IA (T1\\*, N0, M0), IB ((T0, N1mi, M0) or T1\\*, N1mi, M0)) or Stage IIA (T0, N1\\*\\*M0, or T1, N1\\*\\*, M0 or T2, N0, M0)1 breast cancer undergoing surgery to remove tumor draining LNs.\n\n Where:\n * Tis = Ductal carcinoma in situ\n * T0 = No evidence of primary tumor\n * T1 = Tumor ≤ 20 mm in greatest diameter\n * T1\\* = Includes T1mi\n * T2 = Tumor \\>20 mm but ≤ 50 mm in greatest diameter\n * N0 = No regional lymph node metastasisq1'\n * N1 = Metastasis to movable ipsilateral level I, II axillary LNs\n * N1\\*\\* = T0 and T1 tumors with nodal micro-metastasis only are excluded from Stage IIA and are classified Stage IB.\n * mi = Micro-metastasis\n * M0 = Disease has not metastasized from Stage IIA and are classified Stage IB.\n * M0= No evidence of metastasis\n * mi= Micrometastasis\n3. Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy\n4. Subjects with negative metastatic involvement (M0)\n5. Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline\n6. Have signed an approved informed consent form for the study\n7. Be willing to comply with the protocol\n\nExclusion Criteria:\n\n1. Have had prior axillary surgery or ipsilateral radiation in the breast(s) that is planned for the procedure\n2. Advanced breast cancer subjects with stage IIB, III and IV\n3. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes\n4. Subjects who have participated in another investigational study within 30 days prior to surgery\n5. Pregnant or lactating subject\n6. Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for"}, 'identificationModule': {'nctId': 'NCT03200704', 'acronym': 'FILM-B', 'briefTitle': 'A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novadaq Technologies ULC, now a part of Stryker'}, 'officialTitle': 'Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer', 'orgStudyIdInfo': {'id': 'SPY LNM 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IC2000/SPY-PHI', 'description': 'Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.', 'interventionNames': ['Combination Product: IC2000 and SPY-PHI', 'Combination Product: Tc-99m radioactive colloid and Gamma Probe']}], 'interventions': [{'name': 'IC2000 and SPY-PHI', 'type': 'COMBINATION_PRODUCT', 'description': 'Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer', 'armGroupLabels': ['IC2000/SPY-PHI']}, {'name': 'Tc-99m radioactive colloid and Gamma Probe', 'type': 'COMBINATION_PRODUCT', 'description': 'Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer', 'armGroupLabels': ['IC2000/SPY-PHI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Center for Cancer Care', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist MD Anderson Cancer Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22306', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Health System', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}, {'zip': 'V3H 3W9', 'city': 'Port Moody', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Fraser Health Authority', 'geoPoint': {'lat': 49.28124, 'lon': -122.82457}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU de Québec-Université Laval (Hôpital du Saint-Sacrement)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'David Weintritt, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Breast Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novadaq Technologies ULC, now a part of Stryker', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}