Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT01336803
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2011-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D002813', 'term': 'Chondrosarcoma'}, {'id': 'D012512', 'term': 'Sarcoma, Ewing'}, {'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D012208', 'term': 'Rhabdomyosarcoma'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D010019', 'term': 'Osteomyelitis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052203', 'term': 'Ferrosoferric Oxide'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005296', 'term': 'Ferrous Compounds'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heiked@stanford.edu', 'phone': '650-723-8996', 'title': 'Heike Daldrup-Link', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Feraheme', 'description': 'Intravenous injection of Feraheme, 5 mg Fe/kg\n\nFeraheme: 5 mg Fe/kg iv\n\nMR Scan: Standard of Care', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone Sarcomas', 'description': 'Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) evaluated with ferumoxytol-enhanced MRI.'}, {'id': 'OG001', 'title': 'Osteomyelitis', 'description': 'Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI) was assessed as the difference of mean T2 \\* relaxation time of bone sarcoma and osteomyelitis subjects. The outcome is reported as the difference of the mean T2 \\* values, with standard deviation.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This initial phase of the study was a pilot assessment of participants with bone sarcomas compared to participants with osteomyelitis.'}, {'type': 'SECONDARY', 'title': 'Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone Sarcomas Pre-ferumoxytol & Post-ferumoxytol Contrast', 'description': 'Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) only.'}], 'classes': [{'title': 'Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.80', 'spread': '2.80', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.27', 'spread': '2.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Post-Treatment-24 hours', 'description': 'Differentiation of bone sarcomas pre-ferumoxytol and post-ferumoxytol contrast was assessed by difference of mean T2 \\* relaxation time pre-ferumoxytol and post-ferumoxytol contrast, in bone sarcoma subjects only.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the participants with bone sarcomas were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mean T2 * Relaxation Time for Lymphoma Participants', 'description': 'Participants with lymphoma evaluated with ferumoxytol-enhanced MRI'}, {'id': 'OG001', 'title': 'Mean T2 * Relaxation Time for Bone Sarcoma Participants', 'description': 'Participants with bone sarcoma, evaluated with ferumoxytol-enhanced MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '14.83', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '7.71', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 \\* relaxation time determined by ferumoxytol-enhanced MRI.\n\n.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome includes the participants with bone sarcoma who participated in the pilot study.'}, {'type': 'SECONDARY', 'title': 'Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mean Area Density of CD-68-positive TAM in Lymphoma', 'description': 'CD-68-positive tumor-associated macrophages (TAM) assessed in Lymphoma participants'}, {'id': 'OG001', 'title': 'Mean Area Density of CD-68-positive TAM in Bone Sarcomas', 'description': 'CD-68-positive Tumor associated macrophages(TAMs)in Bone Sarcomas participants'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Differentiation of CD68-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD68-positive TAM in those populations.', 'unitOfMeasure': 'Percentage of CD68-positive TAM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mean Area Density of CD163-positive TAM in Lymphoma', 'description': 'CD163-positive tumor-associated macrophages (TAM) was assessed in participants with lymphoma'}, {'id': 'OG001', 'title': 'Mean Area Density of CD163-positive TAM in Bone Sarcoma', 'description': 'CD163-positive tumor-associated macrophages (TAM) was assessed in participants with bone sarcomas'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Differentiation of CD163-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD163-positive TAM in those populations.', 'unitOfMeasure': 'Percentage area of CD163-positive TAM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Feraheme', 'description': 'Intravenous injection of Feraheme, 5 mg Fe/kg\n\nFeraheme: 5 mg Fe/kg by intravenous adminstration\n\nMR Scan: Standard of Care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Bone Sarcoma', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Osteomyelitis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lymphoma', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Feraheme', 'description': 'Intravenous injection of Feraheme, 5 mg Fe/kg\n\nFeraheme: 5 mg Fe/kg by intravenous adminstration\n\nMR Scan: Standard of Care'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '4.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-04-04', 'size': 1318467, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-02T18:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2011-04-12', 'resultsFirstSubmitDate': '2019-05-03', 'studyFirstSubmitQcDate': '2011-04-14', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-30', 'studyFirstPostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects', 'timeFrame': '24 hours', 'description': 'Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI) was assessed as the difference of mean T2 \\* relaxation time of bone sarcoma and osteomyelitis subjects. The outcome is reported as the difference of the mean T2 \\* values, with standard deviation.'}], 'secondaryOutcomes': [{'measure': 'Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast', 'timeFrame': 'Baseline and Post-Treatment-24 hours', 'description': 'Differentiation of bone sarcomas pre-ferumoxytol and post-ferumoxytol contrast was assessed by difference of mean T2 \\* relaxation time pre-ferumoxytol and post-ferumoxytol contrast, in bone sarcoma subjects only.'}, {'measure': 'Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI', 'timeFrame': '24 hours', 'description': 'Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 \\* relaxation time determined by ferumoxytol-enhanced MRI.\n\n.'}, {'measure': 'Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas', 'timeFrame': '24 hours', 'description': 'Differentiation of CD68-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD68-positive TAM in those populations.'}, {'measure': 'Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas', 'timeFrame': '24 hours', 'description': 'Differentiation of CD163-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD163-positive TAM in those populations.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Cancer', 'Chondrosarcoma', "Ewing's Sarcoma", 'Osteosarcoma', 'Rhabdomyosarcoma', 'Bone Necrosis', 'Bone Sarcoma', 'Osteomyelitis']}, 'descriptionModule': {'briefSummary': 'This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.', 'detailedDescription': 'BACKGROUND; In this study, T1, T2, and T2\\* represent parameters of magnetic resonance imaging (MRI).\n\nThe T1 relaxation time, also known as the spin-lattice relaxation time, is a measure of how quickly the net magnetization vector (NMV) recovers to its ground state in the direction of B0. T1 is assessed immediately post-contrast. A T1-weighted image (T1WI ) is one of the basic pulse sequences in MRI and demonstrates differences in the T1 relaxation times of tissues. A T1WI relies upon the longitudinal relaxation of a tissue\'s net magnetization vector (NMV).\n\nT2 is a time constant for the decay of transverse magnetization arising from natural interactions at the atomic or molecular levels, and be considered the "natural" or "true" T2 of the tissue. However, in any nuclear magnetic resonance (NMR) experiment, transverse magnetization decays much faster than would be predicted by natural atomic and molecular mechanisms. Accordingly, T2 \\* is the time constant for the decay of transverse magnetization as observed in a tissue during a MRI scan, and be considered the"effective T2" (represented as T2\\*). T2\\* is always ≤ T2. In this study, T2 \\* is assessed after 24 hours.\n\nOUTLINE:\n\nPatients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up to 1 hour after infusion and up to 24 hours post-infusion.\n\nPRIMARY OBJECTIVES:\n\n* Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on relatively early post-contrast T1-weighted images.\n* Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on delayed postcontrast T2-weighted images.\n* Establish T2-weighted MR imaging characteristics of iron-labeled mesenchymal stem cell (MSC) in osteonecrotic bone over time, before and after surgical core decompression and bone marrow implantation.\n* Adding a second branch for patients who can not receive ferumoxytol but still getting the MRI exam. These patients will server as controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Age 10 to 21 years\n* Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis\n* Informed consent with assent as appropriate.\n\nEXCLUSION CRITERIA\n\n* Contraindication to MRI\n* Presence of metal implants\n* Need for sedation or anesthesia\n* Claustrophobia\n* Hemosiderosis or hemochromatosis\n* History of allergic reactions to similar compounds will be obtained and patients with positive history of allergic reactions will be excluded from the study\n* Females who are pregnancy or nursing'}, 'identificationModule': {'nctId': 'NCT01336803', 'acronym': 'Osteosarcoma', 'briefTitle': 'Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI', 'orgStudyIdInfo': {'id': 'IRB-20253(osteosarcoma)'}, 'secondaryIdInfos': [{'id': 'SU-04062011-7666', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': 'PEDSBONE0006', 'type': 'OTHER', 'domain': 'OnCore Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feraheme', 'description': 'Intravenous injection of Feraheme, 5 mg Fe/kg', 'interventionNames': ['Drug: Feraheme', 'Procedure: Magnetic Resonance Imaging (MRI) scan']}], 'interventions': [{'name': 'Feraheme', 'type': 'DRUG', 'otherNames': ['ferumoxytol'], 'description': '5 mg/kg by intravenous (IV) administration', 'armGroupLabels': ['Feraheme']}, {'name': 'Magnetic Resonance Imaging (MRI) scan', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance (MR) scan'], 'description': 'Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/', 'armGroupLabels': ['Feraheme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Heike E Daldrup-Link, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Neyssa Marina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heike E Daldrup-Link', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology (General Radiology)', 'investigatorFullName': 'Heike E Daldrup-Link', 'investigatorAffiliation': 'Stanford University'}}}}