Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT06155734
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010235', 'term': 'Paraganglioma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2023-11-16', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Feasibility of real-time in-vivo identification of suspected paraganglioma's using Near-Infrared-fluorescence ICG imaging", 'timeFrame': 'perioperatively/periprocedurally, within 30 minutes after intravenous administration of the fluorescent dye, up until a maximum of 120 minutes after start of surgery.', 'description': 'The primary outcome of this retrospective study is the ability to visually detect the proportion (%) of suspected pre-operatively identified lesions (paraganglioma) in the abdomen during minimally invasive procedures using Near-Infrared-fluorescence ICG imaging'}], 'secondaryOutcomes': [{'measure': 'Accuracy of the detection of suspected lesions using Near-Infrared-fluorescence ICG imaging', 'timeFrame': 'Postoperatively, at the moment the definitive pathology result is known, approximately five days after surgery', 'description': 'The secondary outcome of this retrospective study is the accuracy, measured by sensitivity and specificity to identify abdominal paragangliomas using using Near-Infrared-fluorescence ICG imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorescence Guided Surgery'], 'conditions': ['Paraganglioma']}, 'descriptionModule': {'briefSummary': "This study is exploring whether it's possible to detect paragangliomas (a rare type of tumor) during minimally invasive surgery by using a technique called near-infrared fluorescence imaging, guided by a substance called indocyanine green (ICG). The goal is to see if this method can help surgeons identify and treat paragangliomas more accurately and during minimally invasive procedures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients \\>18yo diagnosed with abdominal paragangliomas which underwent surgical resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with abdominal paraganglioma and underwent minimally-invasive surgical resection\n\nExclusion Criteria:\n\n* Open surgical procedures'}, 'identificationModule': {'nctId': 'NCT06155734', 'briefTitle': 'Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green', 'orgStudyIdInfo': {'id': 'nWMO_GLL_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective intervention cohort', 'interventionNames': ['Drug: Fluorescence guided identification using indocyanine green']}], 'interventions': [{'name': 'Fluorescence guided identification using indocyanine green', 'type': 'DRUG', 'description': 'During minimally invasive surgery using intravenous administration of indocyanine green (ICG) near-infrared fluorescence imaging will be applied to identify and treat paragangliomas', 'armGroupLabels': ['Retrospective intervention cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2300RC', 'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Alexander Vahrmeijer, MD, PhD', 'role': 'CONTACT', 'email': 'a.l.vahrmeijer@lumc.nl'}, {'name': 'Martijn van Dam, MD', 'role': 'CONTACT', 'email': 'm.a.van_dam@lumc.nl'}, {'name': 'Alexander Vahrmeijer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Martijn van Dam, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sven Mieog, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'centralContacts': [{'name': 'Martijn van Dam, MD', 'role': 'CONTACT', 'email': 'm.a.van_dam@lumc.nl', 'phone': '0715298420'}, {'name': 'Alexander L. Vahrmeijer, MD, PhD', 'role': 'CONTACT', 'email': 'a.l.vahrmeijer@lumc.nl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator, oncologic surgeon, MD, PhD', 'investigatorFullName': 'Alexander Vahrmeijer', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}