Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-07 @ 2:24 AM
Study NCT ID:
NCT02209532
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alicia.wilton@stryker.com', 'phone': '416-949-4992', 'title': 'Alicia Wilton', 'organization': 'Novadaq Technologies'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 Days', 'description': 'Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Blue - PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes", 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 13, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'PINPOINT - Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes", 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 10, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Partial bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trace pleural effusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Confirmed Lymph Nodes', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PINPOINT - Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}, {'id': 'OG001', 'title': 'Blue - PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}], 'classes': [{'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.', 'unitOfMeasure': 'Confirmed Lymph Nodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Confirmed Lymph Nodes', 'denomUnitsSelected': 'Confirmed Lymph Nodes', 'populationDescription': 'All analyses were completed using the number of lymph nodes identified.'}, {'type': 'SECONDARY', 'title': 'Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PINPOINT-Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}, {'id': 'OG001', 'title': 'Blue - PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}], 'classes': [{'title': 'IC2000 and PINPOINT', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Isosulfan Blue', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.', 'unitOfMeasure': 'Number of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': '180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).'}, {'type': 'SECONDARY', 'title': 'Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PINPOINT-Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}, {'id': 'OG001', 'title': 'Blue - PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}], 'classes': [{'title': 'IC2000 and PINPOINT', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Isosulfan Blue', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).', 'unitOfMeasure': 'Number of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': '180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).'}, {'type': 'SECONDARY', 'title': 'Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PINPOINT-Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}, {'id': 'OG001', 'title': 'Blue - PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}], 'classes': [{'title': 'IC2000 and PINPOINT', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Isosulfan Blue', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'To determine the proportion of lymph nodes identified from following lymphatic channels', 'unitOfMeasure': 'Number of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': '180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).'}, {'type': 'SECONDARY', 'title': 'Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PINPOINT-Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}, {'id': 'OG001', 'title': 'Blue - PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 30', 'description': 'To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': '180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).'}, {'type': 'SECONDARY', 'title': 'Anatomic Distribution of Lymph Nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Lymph Nodes', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PINPOINT-Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}, {'id': 'OG001', 'title': 'Blue - PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}], 'classes': [{'title': 'Left obturator/internal iliac', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Left external iliac', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Left common iliac', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Right obturator/internal iliac', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Right external iliac', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Right common iliac', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Presacral', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Para-aortic node below IMA', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'To determine the anatomic distribution of lymph nodes', 'unitOfMeasure': 'confirmed lymph nodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lymph Nodes', 'denomUnitsSelected': 'Lymph Nodes', 'populationDescription': '180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lymph Node Mapping With Isosulfan Blue Followed by PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}, {'id': 'FG001', 'title': 'Lymph Node Mapping With PINPOINT Followed by Isosulfan Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Blue - PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}, {'id': 'BG001', 'title': 'PINPOINT - Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.\n\nPINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '30-39', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': '40-49', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '50-59', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': '60-69', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': '70-79', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': '>80', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Past', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Consumption', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ASA Classification', 'classes': [{'title': 'I - A normal healthy patient', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'II - A patient with mild systemic disease', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'III - A patient with severe systemic disease', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Unknown ASA Classification', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative Diagnosis', 'classes': [{'title': 'Stage 1 Endometrial Cancer', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}, {'title': 'Stage 1 Cervical Cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Stage 1A Cervical Cancer', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Endometrial Cancer Histology', 'classes': [{'title': 'Adenocarcinoma', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}, {'title': 'Serous Carcinoma', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Clear Cell Carcinoma', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Carcinosarcoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cervical Cancer Histology', 'classes': [{'title': 'Squamous Cell Carcinoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Adenocarcinoma', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment) therefore, 176 subjects were included in the Baseline analysis population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-25', 'size': 2282543, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-11-19T23:27', 'hasProtocol': True}, {'date': '2017-06-23', 'size': 366369, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-19T23:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-04', 'studyFirstSubmitDate': '2014-07-29', 'resultsFirstSubmitDate': '2018-11-19', 'studyFirstSubmitQcDate': '2014-08-04', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-04', 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified', 'timeFrame': 'Day 0', 'description': 'To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye', 'timeFrame': 'Day 0', 'description': 'To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.'}, {'measure': 'Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye.', 'timeFrame': 'Day 0', 'description': 'To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).'}, {'measure': 'Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye.', 'timeFrame': 'Day 0', 'description': 'To determine the proportion of lymph nodes identified from following lymphatic channels'}, {'measure': 'Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG', 'timeFrame': 'Day 0 to Day 30', 'description': 'To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.'}, {'measure': 'Anatomic Distribution of Lymph Nodes', 'timeFrame': 'Day 0', 'description': 'To determine the anatomic distribution of lymph nodes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lymph node mapping', 'Endometrial cancer', 'Uterine cancer', 'Cervical cancer'], 'conditions': ['Endometrial Cancer', 'Uterine Cancer', 'Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '30143441', 'type': 'DERIVED', 'citation': 'Frumovitz M, Plante M, Lee PS, Sandadi S, Lilja JF, Escobar PF, Gien LT, Urbauer DL, Abu-Rustum NR. Near-infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial. Lancet Oncol. 2018 Oct;19(10):1394-1403. doi: 10.1016/S1470-2045(18)30448-0. Epub 2018 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, prospective, open label, multicenter study to assess the safety and utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older\n* Subjects with FIGO Clinical Stage I endometrial cancer undergoing minimally invasive hysterectomy with lymph node mapping.\n* Subjects with FIGO Clinical Stage IA cervical cancer ≤ 2 cm in size undergoing minimally invasive hysterectomy, trachelectomy, or conization with lymph node mapping. Subjects with clinical Stage IA1 cervical cancer without lympho vascular space involvement (LVSI) and negative margins on cone biopsy are not to be included.\n* Subjects with negative nodal status (N0)\n* Subjects with negative metastatic involvement (M0).\n\nExclusion Criteria:\n\n* Have had prior dissection and/or radiation in pelvis.\n* Advanced cervical or endometrial cancer, T3/T4 lesions\n* Diagnosis of cervical cancer with a tumor size greater than 2 cm.\n* Locally advanced or inflammatory cervical or uterine cancer\n* Metastatic cervical or uterine cancer.\n* Known allergy or history of adverse reaction to ICG, iodine or iodine dyes.\n* Known allergy or history of adverse reaction to Blue dye (Isosulfan blue) or triphenylmethane.\n* Hepatic dysfunction defined as MELD Score \\> 12.\n* Renal dysfunction defined as serum creatinine ≥ 2.0 mg/dl.\n* Subjects who have participated in another investigational study within 30 days prior to surgery.\n* Pregnant or lactating subjects.\n* Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results."}, 'identificationModule': {'nctId': 'NCT02209532', 'acronym': 'FILM', 'briefTitle': 'A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novadaq Technologies ULC, now a part of Stryker'}, 'officialTitle': 'A Randomized, Prospective, Open Label, Multicenter Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping', 'orgStudyIdInfo': {'id': 'PP LNM 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Blue - PINPOINT', 'description': "The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.", 'interventionNames': ['Device: PINPOINT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PINPOINT - Blue', 'description': "The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.", 'interventionNames': ['Device: PINPOINT']}], 'interventions': [{'name': 'PINPOINT', 'type': 'DEVICE', 'description': 'PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes', 'armGroupLabels': ['Blue - PINPOINT', 'PINPOINT - Blue']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': "O'Connor Hospital", 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Memorial Hospital', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Science Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU de Québec - Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Caguas', 'country': 'Puerto Rico', 'facility': 'Hospital HIMA San Pablo', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}], 'overallOfficials': [{'name': 'Michael Frumovitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novadaq Technologies ULC, now a part of Stryker', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}