Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-24 @ 1:01 PM
Study NCT ID:
NCT02068820
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2014-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robhollowaymd@gmail.com', 'phone': '407-303-2400', 'title': 'Robert W. Holloway', 'organization': 'Florida Hospital Gynecologic Oncology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Post-op follow up 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'ISB Only Adverse Events', 'description': 'ISB only Adverse Events categories reported during post-op follow up 6 weeks', 'otherNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ICG Adverse Events', 'description': 'ICG Adverse Events categories reported during post-op follow up 6 weeks', 'otherNumAtRisk': 180, 'otherNumAffected': 29, 'seriousNumAtRisk': 180, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Reproductive system complications', 'notes': 'The following were effected:\n\nVaginal discharge Vasomotor symptoms Vaginal spotting Uterovaginal fistula Vaginal bleeding Pelvic abscess Vaginal leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 7}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary complications', 'notes': 'The following were effected:\n\nAcute renal insufficiency Polyuria Transient right hydronephrosis Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound complications', 'notes': 'The following were effected:\n\nWound dehiscence Wound seroma Left incisional drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'notes': 'The following were effected:\n\nCellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic, and pulmonary complications', 'notes': 'The following were effected:\n\nPulmonary embolism Pleural effusions Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac complications', 'notes': 'The following were effected:\n\nCardiac complications Tachycardia Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular complications', 'notes': 'The following were effected:\n\nDeep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal complications', 'notes': 'The following were effected:\n\nSmall bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions', 'notes': 'The following were effected:\n\nHypotension Hypertension Lymphedema Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system complications', 'notes': 'The following were effected:\n\nLeukocytosis Anemia Thrombocytopenia Neutropenia Lymphatic ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISB Dye, Standard White Light', 'description': 'SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.\n\nISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.'}, {'id': 'OG001', 'title': 'ICG Dye, FireFly Fluorescence Imaging', 'description': 'SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.\n\nISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.\n\nICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'spread': '.901', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '.720', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through 6 weeks post-operative', 'unitOfMeasure': 'nodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ISB dye alone group (n=20) and the ICG group (n=180) are combined, because both groups received the ISB dye.'}, {'type': 'SECONDARY', 'title': 'Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ICG Negative', 'description': 'Experimental subjects with Indocyanine Green (ICG) negative test results'}, {'id': 'OG001', 'title': 'ICG Positive', 'description': 'Experimental subjects with Indocyanine Green (ICG) positive test results'}], 'classes': [{'title': 'Metastatic Disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Non Metastatic Disease', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through 6 weeks post-operative', 'description': 'The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients.\n\nNPV = 140/141=99.3%', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison of metastatic disease (yes or no) with ICG dye node detection (yes or no)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}]}, {'units': 'Nodes', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IHC Only', 'description': 'Positive node identified with IHC dye only'}, {'id': 'OG001', 'title': 'H&E Only', 'description': 'Positive node identified with H\\&E only'}, {'id': 'OG002', 'title': 'Both IHC and H&E', 'description': 'Positive node identified with both IHC and H\\&E dye'}], 'classes': [{'title': 'Sentinel Nodes', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Pelvic Nodes Only', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Aortic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infrarenal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through 6 weeks post-operative', 'description': 'Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence.', 'unitOfMeasure': 'nodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Nodes', 'denomUnitsSelected': 'Nodes', 'populationDescription': 'These are positive sentinel lymph nodes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ISB Dye, Standard White Light', 'description': 'SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.\n\nISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.'}, {'id': 'FG001', 'title': 'ICG Dye, FireFly Fluorescence Imaging', 'description': 'SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.\n\nISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.\n\nICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ISB Dye, Standard White Light', 'description': 'SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.\n\nISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.'}, {'id': 'BG001', 'title': 'ICG Dye, FireFly Fluorescence Imaging', 'description': 'SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.\n\nISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.\n\nICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age', 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2014-02-14', 'resultsFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-20', 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).', 'timeFrame': 'through 6 weeks post-operative', 'description': 'Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence.'}], 'primaryOutcomes': [{'measure': 'Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.', 'timeFrame': 'through 6 weeks post-operative'}], 'secondaryOutcomes': [{'measure': 'Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.', 'timeFrame': 'through 6 weeks post-operative', 'description': 'The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients.\n\nNPV = 140/141=99.3%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sentinel lymph nodes', 'da Vinci', 'Firefly', 'Sentinel lymph node mapping', 'Fluorescence Imaging', 'SLN', 'SLN mapping'], 'conditions': ['Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H\\&E pathologic analysis.', 'detailedDescription': 'The study objective is to compare two sentinel lymph node detection technologies \\[fluorescence imaging and Indocyanine Green (ICG) dye verses standard laparoscopic colorimetric analysis using Isosulfan Blue (ISB) dye\\] for sensitivity and specificity of detecting metastatic disease in pelvic lymph nodes of women with endometrial cancer undergoing robotic-assisted laparoscopic hysterectomy and lymphadenectomy. The following three specific aims would be addressed in this research proposal:\n\nSpecific Aim 1: To determine the ability of mapping bilaterally pelvic SLN in women with endometrial cancer undergoing robotic-assisted laparoscopic staging comparing two different methods (i.e., comparing the combination of colorimetric analysis-ISB dye + fluorescence imaging-ICG dye vs. colorimetric analysis-ISB dye alone).\n\nSpecific Aim 2: To estimate the negative predictive value (NPV) of pelvic SLN in endometrial cancer with respect to predicting nodal metastasis.\n\nSpecific Aim 3: To evaluate the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H\\&E) results.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient must be ≥18 and ≤85 years of age.\n2. The patient must be female.\n3. The patient must be willing and able to provide informed consent.\n4. The patient is willing and able to comply with the study protocol.\n5. The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy.\n6. The patient agrees to follow-up examinations out to 6-weeks post-treatment\n\nExclusion Criteria:\n\n1. The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy.\n2. The patient has known or suspected allergies to iodine, ICG or ISB.\n3. The patient has hepatic dysfunction confirmed by elevated liver function studies (i.e., hepatic enzyme SGOT, SGPT or Bilirubin \\> 2 x normal (based on reference values from the laboratory used by the patient)'}, 'identificationModule': {'nctId': 'NCT02068820', 'briefTitle': 'Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue (ISB) and Indocyanine Green Dyes (ICG) With Fluorescence Imaging', 'orgStudyIdInfo': {'id': 'SLN Mapping'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ISB dye, standard white light', 'description': 'SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.', 'interventionNames': ['Device: ISB dye and standard white light imaging']}, {'type': 'EXPERIMENTAL', 'label': 'ICG dye, FireFly fluorescence imaging', 'description': 'SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.', 'interventionNames': ['Device: ISB dye and standard white light imaging', 'Device: ICG dye and FireFly fluorescence imaging']}], 'interventions': [{'name': 'ISB dye and standard white light imaging', 'type': 'DEVICE', 'otherNames': ['Isosulfan Blue dye'], 'description': 'Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.', 'armGroupLabels': ['ICG dye, FireFly fluorescence imaging', 'ISB dye, standard white light']}, {'name': 'ICG dye and FireFly fluorescence imaging', 'type': 'DEVICE', 'otherNames': ['Indocyanine green dye'], 'description': 'Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.', 'armGroupLabels': ['ICG dye, FireFly fluorescence imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Gynecologic Oncology', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Robert Holloway, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Hospital Gynecologic Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}