Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-28 @ 9:54 PM
Study NCT ID:
NCT04273334
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2020-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603981', 'term': "68Ga-1,4,7-triazacyclononane-N,N',N''-triacetic acid"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-15', 'studyFirstSubmitDate': '2020-02-15', 'studyFirstSubmitQcDate': '2020-02-15', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized uptake value of 68Ga NEB in lymphatic lesion', 'timeFrame': '1 years', 'description': 'The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in lymphatic lesion will be measured.'}], 'secondaryOutcomes': [{'measure': 'Adverse events collection', 'timeFrame': '1 week', 'description': 'Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphatic Disorders']}, 'descriptionModule': {'briefSummary': 'This is an open-label whole-body PET/CT study for investigating the value of 68Ga NEB PET imaging in the diagnosis and evaluation of lymphatic disorders including lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.', 'detailedDescription': 'No fasting, hydration or other specific preparation was requested on the day of imaging.\n\nPatients for lymphatic drainage disorders imaging underwent whole-body PET/CT acquisitions 20-40 min after subcutaneously injected into first and second interdigital spaces of both feet or hands of 74-111 MBq (2-3 mCi) 68Ga-NEB with each bed position lasted for 2 min.\n\nA MIM workstation was used for post-processing. The visual method was used to evaluate the lymphatic system, including the morphology and the distribution of the lymphatic system. Semiquantitative methods were applied for image analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to provide a written informed consent; Males and females, ≥18 years old； Diagnostic CT or MRI suggesting a diagnosis of lymphatic system lesion(s). In suspicion of lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.\n\nExclusion Criteria:\n\n* Females planning to bear a child recently or with childbearing potential; Known severe allergy or hypersensitivity to IV radiographic contrast； Inability to lie still for the entire imaging time because of cough, pain, etc. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.\n\nConcurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.'}, 'identificationModule': {'nctId': 'NCT04273334', 'briefTitle': 'Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders, Including Lymphedema, Lymphangioma, Lymphangioleiomyomatosis, Plastic Bronchitis, Lymphadenopathy Caused by Rheumatoid Arthritis, Etc.', 'orgStudyIdInfo': {'id': 'PekingUMCH-NM26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-NEB injection and PET/CT scan', 'description': 'Patients for lymphatic disorders imaging: The patients were subcutaneously injected with 68Ga-NEB and underwent PET/CT scan 20\\~40min after the injection.', 'interventionNames': ['Drug: 68Ga-NEB']}], 'interventions': [{'name': '68Ga-NEB', 'type': 'DRUG', 'otherNames': ["68Ga-NOTA-Even's Blue"], 'description': '68Ga-NEB were injected into the patients before the PET/CT scans', 'armGroupLabels': ['68Ga-NEB injection and PET/CT scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guozhu Hou, MD', 'role': 'CONTACT', 'email': '15611145656@163.com', 'phone': '+86 15611145656'}], 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Guozhu Hou, MD', 'role': 'CONTACT', 'email': '15611145656@163.com', 'phone': '+86 15611145656'}], 'overallOfficials': [{'name': 'Zhaohui Zhu, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}