Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT06735105
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2024-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Value of Three DWI Scanning Sequences in Staging 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 129}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T staging of gastric cancer', 'timeFrame': 'one year', 'description': 'Study on the value of three DWI scanning sequences in T staging of gastric cancer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Accurate staging is critical for effective gastric cancer treatment planning. Conventional DWI (C-DWI) has limitations in image quality due to magnetic field inhomogeneity, which hampers precise T staging.\n\nThis study aims to compare the image quality and T staging accuracy of C-DWI, TSE-DWI, and ZOOMit-DWI (Z-DWI) sequences in MRI examinations of gastric cancer patients.\n\nA prospective study plan to enroll 72 gastric cancer patients undergoing preoperative MRI with C-DWI, TSE-DWI, and Z-DWI sequences using a 3.0 T scanner. Quantitative metrics (ADC, SNR, CNR) and image quality were evaluated. T staging accuracy was assessed by comparing MRI results with postoperative pathological staging using ROC analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient was diagnosed with gastric cancer by pathological biopsy\n2. No biopsy was taken within 1 week before MR Examination to rule out the effect of bleeding on the image\n3. No contraindications for MRI examination; And exclude serious heart, liver, kidney, cerebrovascular diseases.\n\nExclusion Criteria:\n\n1. The image quality cannot meet the diagnostic criteria;\n2. Patients could not tolerate MRI examination, resulting in incomplete MR-related sequence image data.'}, 'identificationModule': {'nctId': 'NCT06735105', 'briefTitle': 'Study on the Value of Three DWI Scanning Sequences in Staging of Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Yunnan Cancer Hospital'}, 'officialTitle': 'Comparative Study on the Value of Three DWI Scan Sequences of 3.0T Magnetic Resonance in Staging of Gastric Cancer', 'orgStudyIdInfo': {'id': 'KYLX2023-167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'SS-EPI-DWI T-stage of gastric cancer'}, {'type': 'OTHER', 'label': 'TSE-DWI T-stage of gastric cancer', 'interventionNames': ['Diagnostic Test: Scanning parameter']}, {'type': 'OTHER', 'label': 'ZOOM-DWI T-stage of gastric cancer', 'interventionNames': ['Diagnostic Test: Scanning parameter']}], 'interventions': [{'name': 'Scanning parameter', 'type': 'DIAGNOSTIC_TEST', 'description': 'Based on abdominal scanning, TSE-DWI,ZOOMIT DWI and EPI-DWI scans were performed, and the study was divided into two steps according to the nanomotion criteria. The first step was self-controlled, which was divided into experimental group and control group. The experimental group included TSE-DWI,ZOOMit DWI, and the control group included EPI-DWI. Then the image quality was evaluated by subjective and objective evaluation indexes. In the second step, the three DWI stages were performed separately by four diagnosticians, with an interval of 1 month, and statistical analysis was performed at the end.', 'armGroupLabels': ['TSE-DWI T-stage of gastric cancer', 'ZOOM-DWI T-stage of gastric cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kunming', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang Guojun, Professor', 'role': 'CONTACT', 'phone': '0871-68173640'}], 'facility': 'Yunnan Cancer Hospital', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Li Yanli, master', 'role': 'CONTACT', 'email': 'lyl2241@163.com', 'phone': '18987958050'}, {'name': 'Li Zhenhui, MD', 'role': 'CONTACT', 'email': 'lizhenhui@kmmu.edu.cn', 'phone': '13698736132'}], 'overallOfficials': [{'name': 'Lianhua Ye', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ethics Committee of Yunnan Provincial Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yunnan Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}