Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-22 @ 5:12 AM
Study NCT ID:
NCT06607250
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2024-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bp-MRI Based Multi-planar VI-RADS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VI-RADS score', 'timeFrame': 'Immediately after enrollment', 'description': 'All enrolled patients underwent multiparametric MRI, which included T2WI (coronal, sagittal, axial planes) and diffusion-weighted imaging (DWI) in the coronal, sagittal, and axial planes to evaluate the VI-RADS score. A VI-RADS score of ≥3 and ≥4 were used as cutoff values for the diagnosis of MIBC.'}], 'secondaryOutcomes': [{'measure': 'statistical analysis', 'timeFrame': '1 day', 'description': 'Sensitivity, specificity in predicting muscle invasive bladder cancer.'}, {'measure': 'positive predictive value (PPV), negative predictive value (NPV)', 'timeFrame': '1 day', 'description': 'statistical analysis'}, {'measure': 'the Receiver Operating Characteristic (ROC) curve', 'timeFrame': '1 day', 'description': 'statistical analysis'}, {'measure': 'statistical analysis', 'timeFrame': '1 day', 'description': 'the area under the curve (AUC) of the vi-rads score in predicting muscle invasive bladder cancer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder (Urothelial, Transitional Cell) Cancer', 'MRI']}, 'descriptionModule': {'briefSummary': "This study is a prospective, single-center, observational clinical trial, enrolling 100 patients with malignant bladder tumors admitted to the Department of Urology at the People's Hospital of Jiangsu Province for treatment with transurethral resection or radical cystectomy.\n\nAll enrolled patients underwent multiparametric magnetic resonance imaging, including T2-weighted imaging (T2WI) in coronal, sagittal, and axial planes and diffusion-weighted imaging (DWI) in the same planes. The Vascular Invasion- and Invasion into the Detrusor muscle Assessment and Reporting System (VI-RADS) scores were evaluated for the enrolled patients. Diagnostic thresholds for muscle-invasive bladder cancer (MIBC) were set at VI-RADS scores ≥3 and ≥4, respectively. Descriptive statistics including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated and compared against the surgical pathology gold standard results.\n\nThis study preliminarily validates the diagnostic performance of the 3D magnetic resonance-derived VI-RADS score in the assessment of muscle-invasive bladder cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected bladder tumors due to symptoms such as hematuria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Patients with indications of bladder cancer from preoperative assessments;\n2. Unrestricted by gender;\n3. Age of 18 years or older;\n4. Absence of contraindications for Magnetic Resonance Imaging (MRI);\n5. Provision of informed consent for the use of personal clinical data, pathology, and imaging for research purposes.\n\nExclusion Criteria\n\n1. Time lapse exceeding one month between multiplanar Bp-MRI examination and surgical intervention;\n2. Compromised MRI image quality due to significant artifacts, inadequate bladder filling, or absence of identifiable lesions within the bladder;\n3. Postoperative histopathology confirming non-urothelial bladder cancer;\n4. Inability to undergo surgery due to severe medical conditions, including heart failure, acute myocardial infarction, and severe cardiac or pulmonary diseases, rendering the patient unable to withstand routine surgical procedures;\n5. Recent surgical procedures (e.g., Transurethral Resection of Bladder Tumor, TURBT) prior to MRI examination;\n6. Any conditions identified by investigators that could potentially harm subjects or impede their ability to meet the study requirements;\n7. Inability to provide written informed consent for participation.'}, 'identificationModule': {'nctId': 'NCT06607250', 'briefTitle': 'Bp-MRI Based Multi-planar VI-RADS', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Prospective Study on Biparametric MRI-based Multi-planar VI-RADS for Assessing Muscle Invasion in Bladder Cancer', 'orgStudyIdInfo': {'id': '2024-SR-353'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bladder cancer patients', 'interventionNames': ['Radiation: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'RADIATION', 'description': 'All enrolled patients underwent multiparametric magnetic resonance imaging, encompassing T2-weighted imaging (T2WI) and magnetic resonance diffusion-weighted imaging (DWI), in the coronal, sagittal, and axial planes.', 'armGroupLabels': ['Bladder cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}