Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-04-18 @ 5:59 AM
Study NCT ID:
NCT02678351
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718244', 'term': 'gallium 68 PSMA-11'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anotte@stanford.edu', 'phone': '650-736-4183', 'title': 'Andrea Otte', 'organization': 'Stanford Medicine at Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 72 hours', 'eventGroups': [{'id': 'EG000', 'title': '68Ga-PSMA PET/MRI', 'description': 'Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.\n\n68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '68Ga-PSMA PET/MRI', 'description': 'Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.\n\n68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Day', 'description': '68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '68Ga-PSMA PET/MRI', 'description': 'Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.\n\n68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Day', 'description': 'Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation.'}, {'type': 'SECONDARY', 'title': 'Sensitivity of 68Ga-PSMA-11 PET/MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '68Ga-PSMA PET/MRI', 'description': 'Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.\n\n68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Day', 'description': '68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation.'}, {'type': 'SECONDARY', 'title': 'Specificity of 68Ga-PSMA-11 PET/MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '68Ga-PSMA PET/MRI', 'description': 'Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.\n\n68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Day', 'description': '68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '68Ga-PSMA PET/MRI', 'description': 'Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.\n\n68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '68Ga-PSMA PET/MRI', 'description': 'Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.\n\n68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '74', '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': '70', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '11', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-28', 'size': 564981, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-06T18:13', 'hasProtocol': True}, {'date': '2020-12-01', 'size': 414054, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-03-02T12:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2016-02-02', 'resultsFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-02', 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes', 'timeFrame': '1 Day', 'description': '68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion.'}], 'secondaryOutcomes': [{'measure': 'Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes', 'timeFrame': '1 Day', 'description': 'Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion.'}, {'measure': 'Sensitivity of 68Ga-PSMA-11 PET/MRI', 'timeFrame': '1 Day', 'description': '68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion.'}, {'measure': 'Specificity of 68Ga-PSMA-11 PET/MRI', 'timeFrame': '1 Day', 'description': '68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage II Prostate Adenocarcinoma', 'Stage III Prostate Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '34406051', 'type': 'DERIVED', 'citation': 'Duan H, Baratto L, Hatami N, Liang T, Levin CS, Khalighi MM, Iagaru A. Reduced Acquisition Time per Bed Position for PET/MRI Using 68Ga-RM2 or 68Ga-PSMA-11 in Patients With Prostate Cancer: A Retrospective Analysis. AJR Am J Roentgenol. 2022 Feb;218(2):333-340. doi: 10.2214/AJR.21.25961. Epub 2021 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.', 'detailedDescription': 'OBJECTIVES:\n\n1. To evaluate 68Ga-PSMA-11 PET/MRI for detection of tumor metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection.\n2. To assess sensitivity (positive predictive value) and specificity (negative predictive value) of 68Ga-PSMA-11 PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy.\n\nOUTLINE:\n\nParticipants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.\n\nAfter completion of study, patients are followed up at 24 to 48 hours.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Biopsy-proven prostate adenocarcinoma\n* Planned prostatectomy with lymph node dissection\n* Intermediate- to high-risk disease (as determined by elevated prostate-specific antigen (PSA) \\[PSA \\> 10\\], T stage \\[T2b or greater\\], Gleason score \\[Gleason score \\> 6\\] or other risk factors)\n* Karnofsky performance status of ≥ 50 \\[or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent\\]\n* Diagnostic CT or MRI performed within 90 days of the research PET\n* Able to provide written consent\n\nExCLUSION CRITERIA\n\n* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam\n* Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu)\n* Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery\n* Metallic implants (contraindicated for MRI)'}, 'identificationModule': {'nctId': 'NCT02678351', 'briefTitle': '68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': '68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'IRB-35931'}, 'secondaryIdInfos': [{'id': 'NCI-2016-00092', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'PROS0075', 'type': 'OTHER', 'domain': 'OnCore ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-PSMA PET/MRI', 'description': 'Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.', 'interventionNames': ['Drug: 68Ga-PSMA-11', 'Procedure: Magnetic resonance imaging (MRI)', 'Procedure: Positron Emission Tomography (PET)']}], 'interventions': [{'name': '68Ga-PSMA-11', 'type': 'DRUG', 'otherNames': ['68-gallium prostate-specific membrane antigen 11 positron emission tomography/magnetic resonance imaging', 'HBED CC PSMA', 'DFKZ 11', 'Heidelberg compound'], 'description': 'Undergo 68Ga-PSMA-11 PET/MRI', 'armGroupLabels': ['68Ga-PSMA PET/MRI']}, {'name': 'Magnetic resonance imaging (MRI)', 'type': 'PROCEDURE', 'otherNames': ['Nuclear magnetic resonance imaging', 'MRI imaging', 'NMR Imaging', 'NMRI'], 'description': 'Undergo 68Ga-PSMA-11 PET/MRI', 'armGroupLabels': ['68Ga-PSMA PET/MRI']}, {'name': 'Positron Emission Tomography (PET)', 'type': 'PROCEDURE', 'otherNames': ['PET scan', 'Positron Emission Tomography Scan', 'Proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo 68Ga-PSMA-11 PET/MRI', 'armGroupLabels': ['68Ga-PSMA PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University, School of Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Andrei Iagaru', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrei Iagaru', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiology', 'investigatorFullName': 'Andrei Iagaru', 'investigatorAffiliation': 'Stanford University'}}}}