Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT04636567
Status:
WITHDRAWN
Last Update Posted:
2021-07-02
First Post:
2020-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'C000713247', 'term': 'IRDye 800BK'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Clinical program has been suspended for business reasons.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-30', 'studyFirstSubmitDate': '2020-11-11', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of ureter delineation using a Likert scale to measure ureter visualization', 'timeFrame': 'Surgical procedure duration, estimated up to 5 hours', 'description': 'Evaluation of the pelvic ureter under WL and NIR illumination'}], 'secondaryOutcomes': [{'measure': 'Treatment-Emergent Adverse Events', 'timeFrame': '30 +/- 5 days', 'description': 'Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events'}, {'measure': 'Hourly time point scores concurrence with video review', 'timeFrame': 'Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours)', 'description': 'Three 3-pt Likert scale scores at hourly time points during the procedure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['contrast agent', 'intraoperative monitoring', 'intraoperative procedures', 'near infrared fluorescence', 'minimally invasive'], 'conditions': ['Intraoperative Ureter Injury']}, 'descriptionModule': {'briefSummary': 'Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery (e.g. gynecological, lower gastrointestinal, or other lower abdominal surgery).', 'detailedDescription': 'The primary objective of this study is to assess the acceptance of near-infrared (NIR) fluorescence imaging (650 to 900 nm) compared to white light (WL) using 3 3-point Likert scales.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provide written informed consent prior to the initiation of study procedures.\n* At least 18 years of age.\n* Consent to undergo minimally invasive, lower pelvic surgery.\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent.\n* Unwilling or unable to comply with the requirements of the protocol.\n* Females who are pregnant, lactating, or planning a pregnancy throughout the study.\n* Patients administered indocyanine green (ICG) at the same time of the lower pelvic surgery.\n* Have known allergies to D-mannitol and/or citric acid.\n* Participation in another clinical trial involving a drug in the past 12 weeks.\n* Any other condition that, in the investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy of the investigational product, or determined not a safe candidate for surgery based on standard of care for current medical condition."}, 'identificationModule': {'nctId': 'NCT04636567', 'briefTitle': 'Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Li-Cor, Inc.'}, 'officialTitle': 'A Phase 2 Open-label Study to Evaluate the Use of Nerindocianine as a Surgical Aid in the Delineation of Abdominopelvic Ureter Anatomy Via Near-infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery', 'orgStudyIdInfo': {'id': 'LICOR-10417-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerindocianine for injection', 'description': 'One Arm: Nerindocianine for Injection (0.055 mg/kg body weight); solution, intravenous, one time administration during surgery.', 'interventionNames': ['Drug: Nerindocianine for injection']}], 'interventions': [{'name': 'Nerindocianine for injection', 'type': 'DRUG', 'otherNames': ['IRDye 800BK'], 'description': 'Procedure: routine minimally invasive abdominopelvic surgery.', 'armGroupLabels': ['Nerindocianine for injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center/Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Giovanna Da Silva Southwich, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic Florida'}, {'name': 'Jubilee Brown, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolinas Medical Center / Levine Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Li-Cor, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}