Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT06421103
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micro-dosing Indocyanine Green (ICG) in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Dose escalation with backfilling.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-05-15', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimum clinically useful dose of ICG in children', 'timeFrame': '60 minutes (intra-operative)', 'description': 'Identify the minimum dose of ICG at which intra-operative perfusion assessment is achieveable. Assessment will be based objectively on mean fluorescence intensity and the fluorescence-time curve, and subjectively by the operating surgeon.'}, {'measure': 'Number of adverse drug events at each dose level', 'timeFrame': '30 days', 'description': 'An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product'}], 'secondaryOutcomes': [{'measure': 'Surgical complications', 'timeFrame': '30 days', 'description': 'Intra-operative and early postoperative complications and mortality (defined as an event observed within 30 days after surgery). Frequency and details.'}, {'measure': 'Post-operative morbidity', 'timeFrame': '90 days', 'description': 'Further procedures, complications and mortality occuring within the 30 - 90 day time period (late post-operative complications). Frequency and details.'}, {'measure': 'Length of stay', 'timeFrame': '90 days', 'description': 'Time in hospital post-procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paediatric Surgery', 'Pediatric Surgery', 'Fluorescence', 'Imaging', 'Fluorescence Guided Surgery (FGS)', 'Intra-operative perfusion assessment', 'Indocyanine Green'], 'conditions': ['Perfusion', 'Fluorescence Imaging', 'Gastrointestinal Tract Disorders', 'Genitourinary Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this cohort study is to identify the lowest dose of Indocyanine Green (ICG) that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children.', 'detailedDescription': 'Indocyanine Green (ICG) fluorescence-guided surgery (FGS) can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively. In adults, the use of ICG has been shown to improve surgical outcomes. ICG is safely used intra-operatively in children, but there is a lack of evidence regarding the lowest clinically useful dose of ICG.\n\nThis is a single centre open-label dose escalation study that aims to:\n\n1. identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old)\n2. assess the safety profile of intra-operative ICG in children\n3. characterise the intra-operative fluorescence of ICG in children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged ≤18 years of age\n* Elective surgery including gastrointestinal or genitourinary tract perfusion assessment\n\nExclusion Criteria:\n\n* Renal and liver dysfunction\n* Active infection\n* Coagulopathy\n* Complex congenital heart defect\n* Previous documented allergy to ICG injection or other iodinated contrast agents\n* Patients suffering from hyperthyroidism or autonomic thyroid adenomas\n* Premature infants or neonates in whom exchange transfusion is indicated, due to the hyperbilirubinaemia risk\n* Concurrent use of sodium bisulphite-containing preparations, such as certain heparin preparations'}, 'identificationModule': {'nctId': 'NCT06421103', 'briefTitle': 'Micro-dosing Indocyanine Green (ICG) in Children', 'organization': {'class': 'OTHER', 'fullName': 'Great Ormond Street Hospital for Children NHS Foundation Trust'}, 'officialTitle': 'Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.', 'orgStudyIdInfo': {'id': '23BO01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Micro-dosing Indocyanine Green (ICG)', 'description': 'Multiple dose levels of intravenous Indocyanine Green (ICG) administered intra-operatively. Starting dose will be 10% of standard (for the study institution) and escalated as per protocol.', 'interventionNames': ['Drug: Indocyanine Green (ICG)']}], 'interventions': [{'name': 'Indocyanine Green (ICG)', 'type': 'DRUG', 'otherNames': ['Verdye by DiagnosticGreen'], 'description': 'Cohorts will receive 0.01 mg/kg, 0.02 mg/kg, 0.04mg/kg, 0.06 mg/kg, or 0.08 mg/kg intra-venous ICG at surgery. Patients will be consecutively allocated to different doses as per protocol.', 'armGroupLabels': ['Micro-dosing Indocyanine Green (ICG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1N 3JH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stefano Giuliani', 'role': 'CONTACT', 'email': 'stefano.giuliani@gosh.nhs.uk', 'phone': '02074059200', 'phoneExt': '0669'}], 'facility': 'Great Ormond Street Hospital for Children', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Stefano Giuliani', 'role': 'CONTACT', 'email': 'stefano.giuliani@gosh.nhs.uk', 'phone': '02074059200', 'phoneExt': '0669'}], 'overallOfficials': [{'name': 'Stefano Giuliani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Great Ormond Street Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Great Ormond Street Hospital for Children NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}