Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT01053312
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2010-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006850', 'term': 'Hydrocephalus, Normal Pressure'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581552', 'term': 'flutemetamol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paulsherwin@ge.com', 'phone': '1-609-514-6820', 'title': 'Paul Sherwin, MD', 'organization': 'GE Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Flutemetamol Injection', 'description': '\\[18F\\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \\[18F\\]flutemetamol will be 185 megabecquerels(MBq).', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blood Pressure Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood Glucose Decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Subject 201-0001', 'description': '\\[18F\\]flutemetamol Injection-less than 10µg of flutemetamol.'}, {'id': 'OG001', 'title': 'Subject 201-0002', 'description': '\\[18F\\]flutemetamol Injection-less than 10µg of flutemetamol.'}, {'id': 'OG002', 'title': 'Subject 201-0003', 'description': '\\[18F\\]flutemetamol Injection-less than 10µg of flutemetamol.'}, {'id': 'OG003', 'title': 'Subject 201-0004', 'description': '\\[18F\\]flutemetamol Injection-less than 10µg of flutemetamol.'}, {'id': 'OG004', 'title': 'Subject 201-0005', 'description': '\\[18F\\]flutemetamol Injection-less than 10µg of flutemetamol.'}, {'id': 'OG005', 'title': 'Subject 201-0006', 'description': '\\[18F\\]flutemetamol Injection-less than 10µg of flutemetamol.'}, {'id': 'OG006', 'title': 'Subject 201-0007', 'description': '\\[18F\\]flutemetamol Injection-less than 10µg of flutemetamol.'}], 'classes': [{'title': 'Brain Region-Cerebellum-VOI surrounding biopsy', 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000'}, {'value': '1.56', 'groupId': 'OG001'}, {'value': '1.25', 'groupId': 'OG002'}, {'value': '2.17', 'groupId': 'OG003'}, {'value': '2.07', 'groupId': 'OG004'}, {'value': '1.39', 'groupId': 'OG005'}, {'value': '1.00', 'groupId': 'OG006'}]}]}, {'title': 'Brain Region-Cerebellum-Contralateral biopsy', 'categories': [{'measurements': [{'value': '1.77', 'groupId': 'OG000'}, {'value': '1.93', 'groupId': 'OG001'}, {'value': '1.16', 'groupId': 'OG002'}, {'value': '2.32', 'groupId': 'OG003'}, {'value': '2.08', 'groupId': 'OG004'}, {'value': '1.18', 'groupId': 'OG005'}, {'value': '0.86', 'groupId': 'OG006'}]}]}, {'title': 'Brain Region-Cerebellum-Anterior Cingulate', 'categories': [{'measurements': [{'value': '2.19', 'groupId': 'OG000'}, {'value': '2.36', 'groupId': 'OG001'}, {'value': '1.44', 'groupId': 'OG002'}, {'value': '2.81', 'groupId': 'OG003'}, {'value': '2.65', 'groupId': 'OG004'}, {'value': '1.26', 'groupId': 'OG005'}, {'value': '1.27', 'groupId': 'OG006'}]}]}, {'title': 'Brain Region-Cerebellum-Frontal Cortex', 'categories': [{'measurements': [{'value': '2.24', 'groupId': 'OG000'}, {'value': '2.78', 'groupId': 'OG001'}, {'value': '1.32', 'groupId': 'OG002'}, {'value': '2.71', 'groupId': 'OG003'}, {'value': '2.74', 'groupId': 'OG004'}, {'value': '1.28', 'groupId': 'OG005'}, {'value': '1.19', 'groupId': 'OG006'}]}]}, {'title': 'Brain Region-Cerebellum-Lateral Temporal Cortex', 'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000'}, {'value': '2.35', 'groupId': 'OG001'}, {'value': '1.45', 'groupId': 'OG002'}, {'value': '2.56', 'groupId': 'OG003'}, {'value': '2.63', 'groupId': 'OG004'}, {'value': '1.52', 'groupId': 'OG005'}, {'value': '1.32', 'groupId': 'OG006'}]}]}, {'title': 'Brain Region-Cerebellum-Parietal Cortex', 'categories': [{'measurements': [{'value': '1.99', 'groupId': 'OG000'}, {'value': '2.38', 'groupId': 'OG001'}, {'value': '1.38', 'groupId': 'OG002'}, {'value': '2.84', 'groupId': 'OG003'}, {'value': '2.27', 'groupId': 'OG004'}, {'value': '1.36', 'groupId': 'OG005'}, {'value': '1.35', 'groupId': 'OG006'}]}]}, {'title': 'Brain Region-Cerebellum-Posterior Cortex', 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000'}, {'value': '2.33', 'groupId': 'OG001'}, {'value': '1.40', 'groupId': 'OG002'}, {'value': '2.86', 'groupId': 'OG003'}, {'value': '2.73', 'groupId': 'OG004'}, {'value': '1.17', 'groupId': 'OG005'}, {'value': '1.73', 'groupId': 'OG006'}]}]}, {'title': 'Brain Region-Cerebellum-Composite VOI', 'categories': [{'measurements': [{'value': '2.13', 'groupId': 'OG000'}, {'value': '2.48', 'groupId': 'OG001'}, {'value': '1.39', 'groupId': 'OG002'}, {'value': '2.74', 'groupId': 'OG003'}, {'value': '2.62', 'groupId': 'OG004'}, {'value': '1.34', 'groupId': 'OG005'}, {'value': '1.34', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-contrast administration', 'description': "Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV\\_voi/SUV\\_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV\\_voi) or reference region (SUV\\_ref). VOI means volume of interest and REF means reference region.", 'unitOfMeasure': 'Standard Uptake Value Ratio (SUVR)', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Subject 201-0001', 'description': '\\[18F\\]flutemetamol Injection-(less than 10µg of flutemetamol).'}, {'id': 'OG001', 'title': 'Subject 201-0002', 'description': '\\[18F\\]flutemetamol Injection-(less than 10µg of flutemetamol).'}, {'id': 'OG002', 'title': 'Subject 201-0003', 'description': '\\[18F\\]flutemetamol Injection-(less than 10µg of flutemetamol).'}, {'id': 'OG003', 'title': 'Subject 201-0004', 'description': '\\[18F\\]flutemetamol Injection-(less than 10µg of flutemetamol).'}, {'id': 'OG004', 'title': 'Subject 201-0005', 'description': '\\[18F\\]flutemetamol Injection-(less than 10µg of flutemetamol).'}, {'id': 'OG005', 'title': 'Subject 201-0006', 'description': '\\[18F\\]flutemetamol Injection-(less than 10µg of flutemetamol).'}, {'id': 'OG006', 'title': 'Subject 201-0007', 'description': '\\[18F\\]flutemetamol Injection-(less than 10µg of flutemetamol).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.127', 'groupId': 'OG000'}, {'value': '0.447', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.007', 'groupId': 'OG003'}, {'value': '0.4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-contrast administration', 'description': 'This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.', 'unitOfMeasure': 'Percent plaque area', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amyloid Level (Plaque Load)', 'description': 'Amlyoid level estimate from the Immunohistochemistry assay: Percent plaque area (average across slides) for mAb NAB228.'}], 'classes': [{'title': 'Subject-201-0001', 'categories': [{'measurements': [{'value': '0.127', 'groupId': 'OG000'}]}]}, {'title': 'Subject-201-0002', 'categories': [{'measurements': [{'value': '0.447', 'groupId': 'OG000'}]}]}, {'title': 'Subject-201-0003', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subject-201-0004', 'categories': [{'measurements': [{'value': '1.007', 'groupId': 'OG000'}]}]}, {'title': 'Subject-201-0005', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Subject-201-0006', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subject-201-0007', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.098', 'groupIds': ['OG000'], 'paramType': 'R²', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.688', 'groupDescription': 'Contralateral to the biopsy Site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The level of association between SUVR and the amyloid levels was analyzed using a regression model.'}, {'pValue': '0.268', 'groupIds': ['OG000'], 'paramType': 'R²', 'paramValue': '0.482', 'groupDescription': 'Ipsilateral to the biopsy Site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The level of association between SUVR and the amyloid levels was analyzed using a regression model.'}, {'pValue': '0.099', 'groupIds': ['OG000'], 'paramType': 'R²', 'paramValue': '0.685', 'groupDescription': 'Composite Region', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The level of association between SUVR and the amyloid levels was analyzed using a regression model.'}], 'paramType': 'NUMBER', 'timeFrame': 'Post-contrast Administration', 'description': 'Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of \\[18F\\] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.', 'unitOfMeasure': 'Percentage of Plaque', 'reportingStatus': 'POSTED', 'populationDescription': 'Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of \\[18F\\] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flutemetamol Injection', 'description': '\\[18F\\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \\[18F\\]flutemetamol will be 185 megabecquerels(MBq).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Flutemetamol Injection', 'description': '\\[18F\\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \\[18F\\]flutemetamol will be 185 megabecquerels(MBq).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-07', 'studyFirstSubmitDate': '2010-01-19', 'resultsFirstSubmitDate': '2012-03-28', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-02', 'studyFirstPostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.', 'timeFrame': 'Post-contrast administration', 'description': "Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV\\_voi/SUV\\_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV\\_voi) or reference region (SUV\\_ref). VOI means volume of interest and REF means reference region."}, {'measure': 'Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.', 'timeFrame': 'Post-contrast administration', 'description': 'This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.'}], 'secondaryOutcomes': [{'measure': 'Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects', 'timeFrame': 'Post-contrast Administration', 'description': 'Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of \\[18F\\] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Amyloid', 'NPH Normal pressure hydrocephalus', 'PET Positron Emission Tomography', 'SUVR Standard uptake value ratios'], 'conditions': ['Normal Pressure Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'This study will determine the level of association between the quantitative estimates of brain uptake of \\[18F\\]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject is 50 years old or older.\n* The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid.\n* Informed consent has been signed and dated by the subject/and/or subjects' legally acceptable representative, if applicable, in accordance with local regulations.\n\nExclusion Criteria:\n\n* The subject has a contraindication for MRI or PET.\n* The subject has a known or suspected hypersensitivity/allergy to \\[18F\\]flutemetamol.\n* The subject has participated in any clinical study using an investigational agent within 30 days of dosing."}, 'identificationModule': {'nctId': 'NCT01053312', 'briefTitle': 'PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied', 'orgStudyIdInfo': {'id': 'GE 067-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 flutemetamol', 'interventionNames': ['Drug: [18F] Flutemetamol']}], 'interventions': [{'name': '[18F] Flutemetamol', 'type': 'DRUG', 'otherNames': ['Flutemetamol', 'AH110690'], 'description': 'All subjects will receive an intravenous (IV) dose of \\[18F\\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \\[18F\\]flutemetamol will be 185 megabecquerels (MBq).', 'armGroupLabels': ['1 flutemetamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GE Healthcare', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], 'overallOfficials': [{'name': 'Kim A Mansfield, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GE Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'i3 Statprobe', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}