Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT02299934
Status:
TERMINATED
Last Update Posted:
2019-05-07
First Post:
2014-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
3T MR Angiography of the Hepatic Vasculature
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'SAMUEL.CHANG@UCDENVER.EDU', 'phone': '720-848-1875', 'title': 'Dr. Samuel Chang', 'organization': 'University of Colorado, Denver'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was terminated prior to collecting any outcome measure data or performing any image analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Duration of study activity (approximately 2 years)', 'description': 'This study was terminated early due to lack of enrollment. No adverse events data was reported prior to early termination', 'eventGroups': [{'id': 'EG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Liver Blood Supply Diameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to collecting any outcome measure data.'}, {'type': 'PRIMARY', 'title': 'The Visibility of the Variations of the Liver Blood Supply', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to collecting any outcome measure data.'}, {'type': 'PRIMARY', 'title': 'Detection Rates of the Variations of the Liver Blood Supply', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to collecting any outcome measure data.'}, {'type': 'PRIMARY', 'title': 'The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to collecting any outcome measure data.'}, {'type': 'PRIMARY', 'title': 'How Badly the Artifacts Prevented Evaluation by the Reader.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to collecting any outcome measure data.'}, {'type': 'PRIMARY', 'title': 'The Relative Signal Intensity of the Liver Blood Supply', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to collecting any outcome measure data.'}, {'type': 'PRIMARY', 'title': 'Documentation of Acquisition Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to collecting any outcome measure data.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Examinations That Caused Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to collecting any outcome measure data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Termination of study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects Who Fulfill the Criteria for Living Liver Donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).\n\nMagnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.\n\nCompurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '13 patients were consented and began the preliminary examination. 11 completed the preliminary examination after consenting.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-28', 'size': 167926, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-15T15:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'lack of support', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2014-11-14', 'resultsFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-15', 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver Blood Supply Diameters', 'timeFrame': 'Day 1'}, {'measure': 'The Visibility of the Variations of the Liver Blood Supply', 'timeFrame': 'Day 1'}, {'measure': 'Detection Rates of the Variations of the Liver Blood Supply', 'timeFrame': 'Day 1'}, {'measure': 'The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation.', 'timeFrame': 'Day 1'}, {'measure': 'How Badly the Artifacts Prevented Evaluation by the Reader.', 'timeFrame': 'Day 1'}, {'measure': 'The Relative Signal Intensity of the Liver Blood Supply', 'timeFrame': 'Day 1'}, {'measure': 'Documentation of Acquisition Time', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Examinations That Caused Adverse Events', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Blood Supply']}, 'referencesModule': {'references': [{'pmid': '22578837', 'type': 'BACKGROUND', 'citation': 'Puippe GD, Alkadhi H, Hunziker R, Nanz D, Pfammatter T, Baumueller S. Performance of unenhanced respiratory-gated 3D SSFP MRA to depict hepatic and visceral artery anatomy and variants. Eur J Radiol. 2012 Aug;81(8):e823-9. doi: 10.1016/j.ejrad.2012.02.016. Epub 2012 May 10.'}]}, 'descriptionModule': {'briefSummary': 'This study plans to learn more about the two Magnetic Resonance Angiography (MRA) techniques.', 'detailedDescription': 'This study will use two Magnetic Resonance Angiography (MRA) techniques that will look at participants liver veins and arteries without giving a coloring matter (contrast) before taking the images. Investigators propose to evaluate the usefulness of these two new techniques, which do not involve exposing participants to radiation or contrast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects that fulfill the criteria for living liver donation and are evaluated for the procedure with CT and MR.\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality MRI studies\n* Not suitable to undergo MRI with a gadolinium-based contrast agent because of:\n\n * Claustrophobia, unless patient agrees to sedation measures per institutional standard practice during MR imaging\n * Presence of metallic objects or implanted medical devices in body per institutional safety standards\n * Weight greater than that allowable by the MR table\n * Renal failure, as determined by estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) model based on a serum creatinine level obtained within 28 days prior to enrollment\n * Known allergy-like reaction to contrast media (gadolinium) or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR), and unwillingness to undergo pre-treatment as defined by the institution's policy and/or ACR guidance\n * Pregnancy (if a female is of childbearing potential --defined as a premenopausal female capable of becoming pregnant --a pregnancy test should be done)"}, 'identificationModule': {'nctId': 'NCT02299934', 'briefTitle': '3T MR Angiography of the Hepatic Vasculature', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': '3T MR Angiography of the Hepatic Vasculature: A Pilot Comparison Study of New Noncontrast Techniques to Post-contrast Technique and CT Angiography in Liver Donors.', 'orgStudyIdInfo': {'id': '14-1213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Subjects who fulfill the criteria for living liver donation', 'description': 'Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging (MRI)', 'Diagnostic Test: Compurtized Tomgraphy (CT)']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI sequences for visualisation of the blood supply of liver without contrast agent.', 'armGroupLabels': ['Subjects who fulfill the criteria for living liver donation']}, {'name': 'Compurtized Tomgraphy (CT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.', 'armGroupLabels': ['Subjects who fulfill the criteria for living liver donation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Samuel Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participant data will only be shared to research personnel.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}