Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-30 @ 6:48 PM
Study NCT ID:
NCT07059832
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of 68Ga-NODAGA-SNA006 Positron Emission Tomography/Computed Tomography (PET/CT) in Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of 68Ga-NODAGA-SNA006-emergent Adverse Events', 'timeFrame': '3 YEAR', 'description': 'Through PET/CT, Visual analysis was positive, or the SUVmax was more than the mediastinum'}, {'measure': 'Biodistribution of 68Ga-NODAGA-SNA006', 'timeFrame': '3 YEAR', 'description': 'Through PET/CT analysis, SUVmax and SUVmean of the organs'}], 'secondaryOutcomes': [{'measure': 'Correlation analysis of 68Ga-NODAGA-SNA006 uptake and tumor immune phenotype', 'timeFrame': '3 YEAR', 'description': 'Correlation coefficients (r²) between SUVmax and SUVmean measured by PET/CT and immunophenotypes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in subjects with solid tumor or lymphoma.', 'detailedDescription': 'The aim of this study was to explore the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in patients with solid tumors or lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants who were diagnosed with malignant tumors;\n2. Patients are between 18 and 80 years of age are between 18 and 80 years of age.\n\nExclusion Criteria:\n\n1. Participants who were unable or unwilling to provide written informed consent.\n2. Participants who were unable to successfully complete the examination and are forced to abort the test in the middle of the test'}, 'identificationModule': {'nctId': 'NCT07059832', 'briefTitle': 'Application of 68Ga-NODAGA-SNA006 Positron Emission Tomography/Computed Tomography (PET/CT) in Tumors', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of China Medical University'}, 'officialTitle': 'Application of 68Ga-NODAGA-SNA006 in Patients With Solid Tumor or Lymphoma', 'orgStudyIdInfo': {'id': '[2024]1161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feasibility and safety of 68Ga-NODAGA-SNA006', 'description': '68Ga-NODAGA-SNA006 0.05 mCi/Kg, interval time between FDG was within five days', 'interventionNames': ['Drug: 68Ga-NODAGA-SNA006']}], 'interventions': [{'name': '68Ga-NODAGA-SNA006', 'type': 'DRUG', 'description': '68Ga-NODAGA-SNA006 PET/CT: after intravenous injection of 0.05 mCi/kg body weight of quality-controlled 68Ga-NODAGA-SNA006, an integrated PET/CT scanner (Biograph mCT; Siemens, Germany) will be applied.', 'armGroupLabels': ['Feasibility and safety of 68Ga-NODAGA-SNA006']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'li', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Hospital of China Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yuxuan Zhao', 'investigatorAffiliation': 'First Hospital of China Medical University'}}}}