Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT06335667
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081364', 'term': 'Multiparametric Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT.', 'timeFrame': 'Up to 1 year', 'description': 'VI-RADS is a five-point scoring system developed to standardize imaging and reporting of bladder tumor invasiveness on mpMRI. It predicts the degree of possible muscular propria invasion ("muscle-invasiveness") of bladder tumors. Once diagnostic TURBT is performed, the VI-RADS score from mpMRI will be compared to the pathologic tumor (T) stage from a diagnostic TURBT to assess for concordance.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS) with mpMRI compared to diagnostic TURBT', 'timeFrame': 'up to 5 years', 'description': 'Time from diagnostic test to cancer progression, recurrence, or death.'}, {'measure': 'Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy', 'timeFrame': 'up to 5 years'}, {'measure': 'Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).', 'timeFrame': 'up to 5 years'}, {'measure': 'Incidence of adverse events with mpMRI versus diagnostic TURBT.', 'timeFrame': 'up to 5 years'}, {'measure': 'Patient Quality of Life with mpMRI versus diagnostic TURBT.', 'timeFrame': 'up to 5 years', 'description': 'As assessed by quality of life questionnaires'}, {'measure': 'Incidence of repeat TURBT.', 'timeFrame': 'up to 5 years'}, {'measure': 'Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT', 'timeFrame': 'up to 5 years', 'description': 'in dollars'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['mpMRI', 'TURBT', 'VI-RADS score'], 'conditions': ['Urothelial Bladder Cancer', 'Muscle-Invasive Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years old or greater at the time of consent.\n* Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated urologist performing this procedure.\n* ECOG Performance Status of 0-3.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).\n* Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Prior TURBT within 120 days of study entry.\n* Prior therapy for bladder cancer within 120 days of study entry.\n* Inability to tolerate mpMRI or associated contrast.\n* Inability to tolerate TURBT or associated anesthesia.\n* ECOG Performance Status of 4.\n* Female patient who is known to be pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06335667', 'briefTitle': 'mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study', 'orgStudyIdInfo': {'id': '4565'}, 'secondaryIdInfos': [{'id': 'UCI 23-72', 'type': 'OTHER', 'domain': 'UCI CFCCC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mpMRI + Diagnostic TURBT', 'interventionNames': ['Diagnostic Test: mpMRI + Diagnostic TURBT']}], 'interventions': [{'name': 'mpMRI + Diagnostic TURBT', 'type': 'DIAGNOSTIC_TEST', 'description': 'mpMRI in addition to the TURBT surgical procedure', 'armGroupLabels': ['mpMRI + Diagnostic TURBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nataliya Mar, MD', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '877-827-8839'}], 'facility': 'Chao Family Comprehensive Cancer Center University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Chao Family Comprehensive Cancer Center University of California, Irvine', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '1-877-827-8839'}, {'name': 'University of California Irvine Medical', 'role': 'CONTACT', 'email': 'marn@hs.uci.edu'}], 'overallOfficials': [{'name': 'Nataliya Mar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chao Family Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nataliya Mar', 'investigatorAffiliation': 'University of California, Irvine'}}}}