Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:56 AM
Study NCT ID:
NCT07449858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-FDG PET/CT Radiomics Models for Precision Diagnosis and Prognosis in NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Performance for TNM Staging and Histological Subtyping', 'timeFrame': 'Baseline', 'description': 'Assessed by the Area Under the Receiver Operating Characteristic Curve (AUC), Sensitivity, and Specificity of the radiomics model in predicting T-stage, N-stage, and histological subtypes (ADC vs. SCC).'}, {'measure': 'Predictive Accuracy for EGFR Mutation Status', 'timeFrame': 'Baseline', 'description': 'Assessed by the AUC, Sensitivity, and Specificity of the radiomics model in discriminating EGFR mutation status (positive vs. negative) compared to genetic testing results.'}, {'measure': 'Prognostic Value', 'timeFrame': 'From date of surgery up to 5 years', 'description': 'Evaluation of Disease-Free Survival (DFS) and Overall Survival (OS). DFS is defined as time to recurrence or death. OS is defined as time to death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['18F-FDG PET/CT', 'Radiomics', 'Artificial Intelligence', 'EGFR Mutation', 'Prognosis'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This multicenter retrospective study aims to investigate the value of 18F-FDG PET/CT radiomics features in the preoperative precision staging, pathological typing, gene mutation status prediction, and prognostic risk stratification of patients with Non-Small Cell Lung Cancer (NSCLC). The study involves constructing and validating machine learning models to provide imaging-based evidence for individualized precision clinical decision-making.', 'detailedDescription': 'The study consists of three main parts based on a multicenter retrospective cohort:\n\nStaging and Typing: Developing radiomics models to distinguish histological subtypes (Adenocarcinoma vs. Squamous Cell Carcinoma) and predict TNM staging preoperatively.\n\nGene Mutation Prediction: Analyzing radiomics signatures to predict EGFR mutation status (Mutant vs. Wild-type) non-invasively.\n\nPrognostic Assessment: Evaluating the prognostic value of radiomics features by analyzing their association with Disease-Free Survival (DFS) and Overall Survival (OS).\n\nHigh-throughput radiomics features will be extracted from standardized PET/CT images and analyzed using machine learning algorithms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pathologically confirmed Non-Small Cell Lung Cancer (NSCLC) who underwent standard preoperative whole-body 18F-FDG PET/CT examinations at The Second Affiliated Hospital of Zhejiang University School of Medicine and other participating tertiary hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years.\n* Underwent standard whole-body 18F-FDG PET/CT scan within 30 days before surgery.\n* Histopathologically confirmed Non-Small Cell Lung Cancer (NSCLC) with clear histological subtyping and complete postoperative TNM staging.\n* Primary tumor SUVmax \\> 2.5 and maximum diameter \\> 1.0 cm on CT.\n* Complete clinical, pathological, and imaging data available.\n* (For Gene Sub-study) Known EGFR gene mutation status.\n* (For Prognosis Sub-study) Complete follow-up data available (minimum 12 months or until endpoint event).\n\nExclusion Criteria:\n\n* History of other malignancies.\n* Received any anti-tumor treatment (chemotherapy, radiotherapy, targeted therapy, immunotherapy) prior to PET/CT.\n* Severe image artifacts or indistinct tumor boundaries affecting ROI delineation.\n* Missing key clinical or pathological data.\n* Baseline PET/CT evaluated recurrent or metastatic tumors instead of primary NSCLC.\n* Extremely short life expectancy due to severe comorbidities.'}, 'identificationModule': {'nctId': 'NCT07449858', 'acronym': 'PET-Rad-NSCLC', 'briefTitle': '18F-FDG PET/CT Radiomics Models for Precision Diagnosis and Prognosis in NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Construction and Validation of Precision Diagnosis and Treatment Models for Non-Small Cell Lung Cancer (NSCLC) Based on 18F-FDG PET/CT Radiomics: A Multicenter Retrospective Clinical Study', 'orgStudyIdInfo': {'id': '2025-0690'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NSCLC Cohort', 'description': 'Patients with pathologically confirmed NSCLC who underwent standard preoperative 18F-FDG PET/CT examination.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510317', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Second Provincial General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Xiaohui Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'Guangdong Second Provincial General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}