Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 7:29 PM
Study NCT ID:
NCT06869694
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy CT in Imaging and Diagnosis of Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic and Predictive performance of Dual-/ Muti- energy CT and MRI in the treatment response and survival prognosis of gastric cancer', 'timeFrame': '3years', 'description': 'Accuracy for both imaging techniques in the prediction of treatment response of gastric cancer.'}], 'secondaryOutcomes': [{'measure': 'The kappa value; One-way analysis of variance; ICC', 'timeFrame': '1year', 'description': 'Consistency of the Photon-counting Detector CT and mpMRI in tumor assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CT', 'Gastric cancer'], 'conditions': ['Gastric Cancer', 'CT']}, 'descriptionModule': {'briefSummary': 'Accurate preoperative prediction of risk stratification, treatment response, and survival prognosis in gastric cancer is important for improving clinical treatment decisions, prolonging patient survival, and improving patient quality of life. The purpose of this study is to investigate the performance of the multi-parametric magnetic resonance imaging (mpMRI) and Dual-/Muti-energy CT and photon-counting Detector CT(PCD-CT) in the diagnosis and management of gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For patients undergoing radical resection, abdominal exploration or palliative tumor resection, CT scanning and dynamic contrast-enhanced magnetic resonance DCE-MRI scanning shall be completed in GSI mode before operation; for patients undergoing neoadjuvant chemotherapy, CT scanning and dynamic contrast-enhanced magnetic resonance DCE-MRI scanning shall be completed in GSI mode before neoadjuvant chemotherapy at least, and if the above scanning mode can still be used during chemotherapy, it is the best choice.\n\nSigned informed consent form. Patients who were diagnosed with gastric cancer at various medical centers were included in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathological biopsy confirmed gastric cancer;\n2. Surgery: patients undergoing radical gastrectomy. Patients undergoing exploratory abdominal surgery or palliative tumor resection were still included in the study when peritoneal metastasis or adjacent organ invasion was identified intraoperatively and radical surgical resection was not possible.\n\nExclusion Criteria:\n\n1. Refusal or inability to sign informed consent;\n2. CT or MRI images are poor or the focus is small and CT images are not clear;\n3. Patients with other tumors complicated with patients with important organ dysfunction.'}, 'identificationModule': {'nctId': 'NCT06869694', 'acronym': 'CTIDGC', 'briefTitle': 'Energy CT in Imaging and Diagnosis of Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'Diagnostic and Predictive Performance of Dual-/ Muti- Energy CT and MRI in the Treatment Response and Survival Prognosis of Gastric Cancer', 'orgStudyIdInfo': {'id': 'PC202409'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GC group', 'description': 'GC patients under ct and mri scan', 'interventionNames': ['Device: computerized tomography']}], 'interventions': [{'name': 'computerized tomography', 'type': 'DEVICE', 'description': 'mpMRI and Photon-counting Detector CT scan', 'armGroupLabels': ['GC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450052', 'city': 'Zhengzhou', 'state': 'China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zihao Zhao', 'role': 'CONTACT', 'email': 'zzh2020@163.com', 'phoneExt': 'Dr'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zihao Zhao, Dr', 'role': 'CONTACT', 'email': 'zzh2020@163.com', 'phone': '0371-66271387'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The First Affiliated Hospital of Zhengzhou University', 'investigatorFullName': 'Zihao Zhao', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}