Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT06755905
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2024-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Indocyanine Green Lymphography in Management of Lingual Lymphatic Malformation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044148', 'term': 'Lymphatic Abnormalities'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-31', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cured (Reduction in dimension greater than 90%)', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'Reduction in dimension greater than 90%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['indocyanine green', 'tongue', 'Lymphatic Malformation'], 'conditions': ['Lymphatic Malformation']}, 'referencesModule': {'references': [{'pmid': '40660315', 'type': 'DERIVED', 'citation': 'Han T, Shi L, Huang S, Shen W. Application value of indocyanine green lymphography in the management of stage I/IIA microcystic lymphatic malformation of the tongue. Head Face Med. 2025 Jul 14;21(1):51. doi: 10.1186/s13005-025-00529-2.'}]}, 'descriptionModule': {'briefSummary': 'To elucidate the application of indocyanine green (ICG) fluorescence angiography in the treatment of childhood tongue cLM (clinically localized malignancy, presumed context here), providing a clearer scientific basis for subsequent targeted interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No previous intervention\n* more than 6 months post-treatment follow-up\n* Stage I or Stage IIa\n\nExclusion Criteria:\n\n* History of iodine allergy\n* Syndromic cLM\n* Severe liver and kidney dysfunction'}, 'identificationModule': {'nctId': 'NCT06755905', 'briefTitle': 'Indocyanine Green Lymphography in Management of Lingual Lymphatic Malformation', 'organization': {'class': 'OTHER', 'fullName': "Nanjing Children's Hospital"}, 'officialTitle': 'Application Value of Indocyanine Green Lymphography in Management of Microcystic Lymphatic Malformation of the Tongue', 'orgStudyIdInfo': {'id': 'NanjingCH0116651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lingual LM with ICGL-guided treatment', 'description': 'indocyanine green lymphography guided resection combined with sclerotherapy', 'interventionNames': ['Procedure: ICGL-guided treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'description': 'lingual LM with conventional treatment', 'interventionNames': ['Procedure: Conventional Treatment group']}], 'interventions': [{'name': 'ICGL-guided treatment', 'type': 'PROCEDURE', 'description': 'Indocyanine green lymphography guided resection combined with sclerotherapy', 'armGroupLabels': ['lingual LM with ICGL-guided treatment']}, {'name': 'Conventional Treatment group', 'type': 'PROCEDURE', 'description': 'Resection with sclerotherapy', 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': "Children's hospital of nanjing medical university", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nanjing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Tao Han', 'investigatorAffiliation': "Nanjing Children's Hospital"}}}}