Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:33 PM
Study NCT ID:
NCT07370805
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2025-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-FAPI PET in Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-07', 'size': 399305, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2026-01-19T20:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-20', 'studyFirstSubmitDate': '2025-12-25', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic efficacy', 'timeFrame': 'through study completion, an average of 1.5 year', 'description': 'Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET Imaging in lung cancer.'}], 'secondaryOutcomes': [{'measure': 'Standard uptake value （SUV）of tumor', 'timeFrame': 'through study completion, 3-4 years', 'description': 'This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean).'}, {'measure': 'Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor', 'timeFrame': 'through study completion, 3-4 years', 'description': 'This measure evaluates the association between baseline 18F-FAPI PET parameters (MTV in cm3, TLG in cm3\\*SUV）'}, {'measure': 'Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients', 'timeFrame': 'through study completion, 3-4 years', 'description': 'PFS will be defined as the time from diagnosis to disease progression or relapse, assessed using the Kaplan-Meier method and Cox proportional hazards model.（PFS in months）'}]}, 'conditionsModule': {'conditions': ['Lung Cancer (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the diagnostic efficacy and prognostic value of 18F-FAPI PET/CT in lung cancer.', 'detailedDescription': "1. Patients clinically suspected or confirmed with lung cancer are required to complete conventional imaging examinations (CT/MR or FDG PET) and undergo ¹⁸F-FAPI PET/CT.\n2. Conduct a detailed inquiry into the patient's medical history to clarify symptoms, signs, and prior medical history (e.g., tumor history, surgical history, biopsy history, radiotherapy history, chemotherapy history, family history, allergy history, etc.), as well as relevant laboratory tests and previous imaging findings (including plain radiography, ultrasound, CT, MRI, 18F-FDG PET/CT, PET/MR, etc.).\n3. For follow-up coordination, you are required to regularly provide your clinical data (e.g., treatment plans, disease progression, etc.) as per the study requirements. This collaboration is essential for completing long-term follow-up, including monitoring the subject's condition, imaging findings, pathological results (such as tumor grading and Ki-67 index), and patient treatment outcomes, to collect prognostic information.\n4. ¹⁸F-FAPI PET/CT and conventional imaging examinations (e.g., CT/MR) were completed prior to enrollment. After enrollment in this study, subjects were not required to undergo additional imaging or laboratory tests, only requiring follow-up without intervention to the clinical treatment plan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '120', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of Lung Cancer\n2. With 18F FAPI PET scan\n\nExclusion Criteria:\n\n1. Concurrent presence of other active malignant tumors or a history of other\n2. malignant tumors within the past 5 years;\n3. Severe uncontrollable diseases or active infections;\n4. Ineligible participants for project informed consent；\n5. Pregnant and lactating women.'}, 'identificationModule': {'nctId': 'NCT07370805', 'briefTitle': '18F-FAPI PET in Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Prospective Clinical Study and Exploration of 18F-FAPI PET/CT Imaging in Lung Cancers', 'orgStudyIdInfo': {'id': 'FirstZhejiangU-FAPI-Lung Ca'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FAPI-Lung-ca', 'description': '18F FAPI PET scans', 'interventionNames': ['Diagnostic Test: 18F-FAPI PET']}], 'interventions': [{'name': '18F-FAPI PET', 'type': 'DIAGNOSTIC_TEST', 'description': '1、Patients clinically suspected or confirmed with lung cancer are required to complete conventional imaging examinations (CT/MR or FDG PET) and undergo ¹⁸F-FAPI PET/CT.', 'armGroupLabels': ['FAPI-Lung-ca']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Donghe Chen Chen', 'role': 'CONTACT', 'email': 'chendonghe@zju.edu.cn', 'phone': '0571-87236431'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Donghe Chen, MD', 'role': 'CONTACT', 'email': 'chendonghe@zju.edu.cn', 'phone': '0571-87236432'}], 'overallOfficials': [{'name': 'Donghe Chen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}