Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 4:34 PM
Study NCT ID:
NCT01431300
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2011-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C109932', 'term': 'gadofosveset trisodium'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'charles.kim@duke.edu', 'phone': '919-684-7284', 'title': 'Charles Kim', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '0.01 mmol/kg', 'description': 'gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.02 mmol/kg', 'description': 'gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.03 mmol/kg', 'description': 'FDA-approved dose for lower extremity arterial imaging\n\ngadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Imaging Quality Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.01 mmol/kg', 'description': 'gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent'}, {'id': 'OG001', 'title': '0.02 mmol/kg', 'description': 'gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent'}, {'id': 'OG002', 'title': '0.03 mmol/kg', 'description': 'FDA-approved dose for lower extremity arterial imaging\n\ngadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 weeks', 'description': 'Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows:\n\n1. poor / nondiagnostic\n2. adequate\n3. good\n4. excellent', 'unitOfMeasure': 'Units on a visualization score scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative Analysis Noise Ratios', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.01 mmol/kg', 'description': 'gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent'}, {'id': 'OG001', 'title': '0.02 mmol/kg', 'description': 'gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent'}, {'id': 'OG002', 'title': '0.03 mmol/kg', 'description': 'FDA-approved dose for lower extremity arterial imaging\n\ngadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent'}], 'classes': [{'title': 'signal to noise ratio', 'categories': [{'measurements': [{'value': '81', 'spread': '17', 'groupId': 'OG000'}, {'value': '119', 'spread': '28', 'groupId': 'OG001'}, {'value': '135', 'spread': '25', 'groupId': 'OG002'}]}]}, {'title': 'contrast to noise ratio', 'categories': [{'measurements': [{'value': '37', 'spread': '14', 'groupId': 'OG000'}, {'value': '60', 'spread': '28', 'groupId': 'OG001'}, {'value': '80', 'spread': '25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12', 'groupDescription': 'signal-to-noise (SNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '43', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19', 'groupDescription': 'contrast-to-noise (CNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '14 weeks', 'description': "Signal-to-noise and contrast-to-noise ratios were calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses. The ratio's were calculated as follows:\n\nSignal-to-noise ratio: signal intensity of vessel segment / standard deviation of signal intensity of the background.\n\nContrast-to-noise ratio = (signal intensity of vessel segment minus signal intensity of adjacent muscle) / standard deviation of signal intensity of the background.", 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.01 mmol/kg of Gadofosveset', 'description': 'Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition'}, {'id': 'FG001', 'title': '0.02 mmol/kg of Gadofosveset', 'description': 'Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition'}, {'id': 'FG002', 'title': '0.03 mmol/kg of Gadofosveset', 'description': 'Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition. This is the FDA-approved dose for lower extremity arterial imaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One subject with indeterminate pregnancy test, subject declined to proceed', 'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '0.01 mmol/kg', 'description': 'gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent'}, {'id': 'BG001', 'title': '0.02 mmol/kg', 'description': 'gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent'}, {'id': 'BG002', 'title': '0.03 mmol/kg', 'description': 'FDA-approved dose for lower extremity arterial imaging\n\ngadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '24.6', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '24.1', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '23.4', 'spread': '6.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-20', 'studyFirstSubmitDate': '2011-09-07', 'resultsFirstSubmitDate': '2013-08-01', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-20', 'studyFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Imaging Quality Score', 'timeFrame': '14 weeks', 'description': 'Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows:\n\n1. poor / nondiagnostic\n2. adequate\n3. good\n4. excellent'}], 'secondaryOutcomes': [{'measure': 'Quantitative Analysis Noise Ratios', 'timeFrame': '14 weeks', 'description': "Signal-to-noise and contrast-to-noise ratios were calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses. The ratio's were calculated as follows:\n\nSignal-to-noise ratio: signal intensity of vessel segment / standard deviation of signal intensity of the background.\n\nContrast-to-noise ratio = (signal intensity of vessel segment minus signal intensity of adjacent muscle) / standard deviation of signal intensity of the background."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['central veins', 'thorax', 'superior vena cava', 'Central vein imaging'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '24045249', 'type': 'DERIVED', 'citation': 'Kim CY, Heye T, Bashir MR, Gebhard TA, Merkle EM. Gadofosveset-enhanced magnetic resonance angiography of the thoracic vasculature in the equilibrium phase: feasibility and impact of dose. J Comput Assist Tomogr. 2013 Sep-Oct;37(5):732-6. doi: 10.1097/RCT.0b013e318299dde9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography of the central veins of the chest, and to determine whether dose reduction can be performed while maintaining image quality. This will be a prospective randomized study, in which healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar. Quantitative and qualitative analysis will be performed on the images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male or female subjects between 18-45 years of age\n\nExclusion Criteria:\n\n* Pregnant and lactating females\n* known renal impairment\n* allergy to gadolinium-based contrast\n* metallic implanted devices\n* claustrophobia.'}, 'identificationModule': {'nctId': 'NCT01431300', 'briefTitle': 'Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants', 'orgStudyIdInfo': {'id': 'Pro00022334'}, 'secondaryIdInfos': [{'id': 'CG 10011', 'type': 'OTHER_GRANT', 'domain': 'Lantheus Medical Imaging'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0.03 mmol/kg', 'description': 'FDA-approved dose for lower extremity arterial imaging', 'interventionNames': ['Drug: gadofosveset']}, {'type': 'EXPERIMENTAL', 'label': '0.02 mmol/kg', 'interventionNames': ['Drug: gadofosveset']}, {'type': 'EXPERIMENTAL', 'label': '0.01 mmol/kg', 'interventionNames': ['Drug: gadofosveset']}], 'interventions': [{'name': 'gadofosveset', 'type': 'DRUG', 'otherNames': ['Ablavar'], 'description': 'Intravenous administration of the specified dosage of gadolinium contrast agent', 'armGroupLabels': ['0.01 mmol/kg', '0.02 mmol/kg', '0.03 mmol/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Charles Y Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lantheus Medical Imaging', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}