Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:43 PM
Study NCT ID:
NCT07464132
Status:
RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, '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': 'RECRUITING', 'startDateStruct': {'date': '2025-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04', 'timeFrame': 'Within 30-120 minutes after intravenous injection of imaging agent', 'description': 'Semi quantitative analysis (measuring lesion standard uptake value (SUV), then calculating lesion SUV to liver/blood pool SUV ratio)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumor', 'Cardiovascular Diseases', 'Pulmonary Fibrosis', 'Rheumatic Immune Diseases Involving Large Blood Vessels', 'Hypertrophic Cardiomyopathy (HCM)', 'Other Hypoxic and Fibroblast Activated Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct clinical research on \\[68Ga\\] Ga-NI-FAPI-04 PET/CT imaging and further investigate its diagnostic value in fibroblast activation related diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1: 18-85 years old\n\n 2: Tumor patients can undergo surgery or biopsy to obtain pathological diagnosis\n\n 3: Ability to understand and sign informed consent forms\n\n 4: Expected survival period exceeding 6 months and able to receive follow-up\n\n 5: Healthy volunteers without chronic medical history of hypertension, diabetes, coronary heart disease, kidney disease, tumor, etc\n\nExclusion Criteria:\n\n* 1: Pregnant or lactating women\n\n 2: Patients allergic to research drug ingredients\n\n 3: Patients with severe liver and kidney dysfunction (blood creatinine levels exceeding 159 μ mol/L)\n\n 4: Patients who participate in other clinical trials and interfere with the results of this study\n\n 5: Patients with severe illness who cannot cooperate with the examination'}, 'identificationModule': {'nctId': 'NCT07464132', 'briefTitle': 'Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases', 'orgStudyIdInfo': {'id': 'I-25PJ0568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NI-FAPI group', 'description': 'Injection of \\[68Ga\\]Ga-NI-FAPI', 'interventionNames': ['Drug: Injection of 68Ga-NI-FAPI']}], 'interventions': [{'name': 'Injection of 68Ga-NI-FAPI', 'type': 'DRUG', 'description': 'Subjects were injected with 68Ga-NI-FAPI at 0.4-0.5mci/kg body weight', 'armGroupLabels': ['NI-FAPI group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang', 'role': 'CONTACT', 'email': 'yfwyw1999@126.com', 'phone': '+86-13021115973'}], 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhu', 'role': 'CONTACT', 'email': 'yfwyw1999@126.com', 'phone': '+86-13021115973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Zhaohui Zhu', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}