Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT04701567
Status:
UNKNOWN
Last Update Posted:
2021-01-08
First Post:
2021-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic and Evaluation of Hepato-pancreatico-biliary Disease With MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-06', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathology findings in focal and/or diffuse liver disease', 'timeFrame': '1 year', 'description': 'Pathology findings in focal and/or diffuse liver disease'}, {'measure': 'Pathology findings in focal and/or diffuse pancreatic disease', 'timeFrame': '1 year', 'description': 'Pathology findings in focal and/or diffuse pancreatic disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases', 'Pancreas Disease']}, 'descriptionModule': {'briefSummary': 'This is a retrospective review of images from patient data. There is no recruitment necessary for this study.\n\nResearch Question: Can advanced multiparametric MRI techniques improve the detection and characterization of focal and diffuse liver disease, accurately assess treatment response and predict patient outcomes based on longitudinal monitoring? Hypotheses: Advanced multiparametric MRI techniques improve the detection, characterization and response assessment of focal and diffuse liver disease and can predict serious liver related outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen.\n* 18 years of age and older.\n\nExclusion Criteria:\n\n* Age less than 18 years.\n* Lack of MRI of the abdomen.\n* Inadequate image quality.\n* Documented rejection to participate in research studies'}, 'identificationModule': {'nctId': 'NCT04701567', 'briefTitle': 'Diagnostic and Evaluation of Hepato-pancreatico-biliary Disease With MRI', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Diagnostik Und Evaluierung Hepato-pankreatiko-biliärer Erkrankungen Mittels Morphologischer Und Funktioneller Magnetresonanztomographie', 'orgStudyIdInfo': {'id': 'BASEC ID 2020-01313'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver disease', 'interventionNames': ['Diagnostic Test: Magnetic resonance imaging']}, {'label': 'Pancreatic disease', 'interventionNames': ['Diagnostic Test: Magnetic resonance imaging']}], 'interventions': [{'name': 'Magnetic resonance imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Advanced multiparametric MRI techniques to diagnose hepatic and pancreatic disease', 'armGroupLabels': ['Liver disease', 'Pancreatic disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Caecilia Reiner, MD', 'role': 'CONTACT', 'phone': '+41442551111'}, {'name': 'Reiner', 'role': 'CONTACT', 'email': 'caecilia.reiner@usz.ch'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Caecilia Reiner, MD', 'role': 'CONTACT', 'email': 'caecilia.reiner@usz.ch', 'phone': '+41442551111'}, {'name': 'Reiner', 'role': 'CONTACT', 'email': 'caecilia.reiner@usz.ch'}], 'overallOfficials': [{'name': 'Caecilia Reiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Radiologist', 'investigatorFullName': 'Caecilia Reiner', 'investigatorAffiliation': 'University of Zurich'}}}}