Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-02 @ 7:19 PM
Study NCT ID:
NCT03081767
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Standard PET/CT vs. Digital PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aiagaru@stanford.edu', 'phone': '6507254711', 'title': 'Andrei Iagaru', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day (average approximately 3 hours).', 'eventGroups': [{'id': 'EG000', 'title': 'Digital PET/CT', 'description': 'Imaging using digital PET/CT.', 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 0, 'seriousNumAtRisk': 199, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard PET/CT', 'description': 'Imaging using standard PET/CT.', 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 0, 'seriousNumAtRisk': 199, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Image Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital PET/CT', 'description': 'Imaging using digital PET/CT.'}, {'id': 'OG001', 'title': 'Standard PET/CT', 'description': 'Imaging using standard PET/CT.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.96', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0000001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Actual P-Value = 3.89597E-42. A P-value of \\<0.05 was considered significant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'an expected average of 3 hours', 'description': 'Diagnostic image quality will be determined using a 5-point Likert Scale that reads:\n\n5 - Diagnostic: Excellent diagnostic image quality;\n\n4 - Diagnostic: Good diagnostic image quality;\n\n3 - Diagnostic: Acceptable diagnostic image quality;\n\n2 - Sub-optimal diagnostic: image quality with limited additional clinical information;\n\n1 - Non-diagnostic: non-diagnostic image quality', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Undergoing Digital PET/CT', 'description': 'Patients referred to Nuclear Medicine undergo imaging on the standard positron emission tomography/computed tomography (PET/CT) and also have imaging performed on the digital PET/CT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Undergoing Digital PET/CT', 'description': 'Patients referred to Nuclear Medicine undergo imaging on the standard PET/CT and also have imaging performed on the digital PET/CT.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '10.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '176', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', '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': '20', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '159', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-12', 'size': 307227, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-16T18:24', 'hasProtocol': True}, {'date': '2022-03-16', 'size': 93256, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-18T12:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-18', 'studyFirstSubmitDate': '2017-03-10', 'resultsFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-18', 'studyFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Image Quality', 'timeFrame': 'an expected average of 3 hours', 'description': 'Diagnostic image quality will be determined using a 5-point Likert Scale that reads:\n\n5 - Diagnostic: Excellent diagnostic image quality;\n\n4 - Diagnostic: Good diagnostic image quality;\n\n3 - Diagnostic: Acceptable diagnostic image quality;\n\n2 - Sub-optimal diagnostic: image quality with limited additional clinical information;\n\n1 - Non-diagnostic: non-diagnostic image quality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PET/CT', 'digital PET/CT'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '34823095', 'type': 'RESULT', 'citation': 'Duan H, Baratto L, Hatami N, Liang T, Mari Aparici C, Davidzon GA, Iagaru A. 68Ga-PSMA11 PET/CT for biochemically recurrent prostate cancer: Influence of dual-time and PMT- vs SiPM-based detectors. Transl Oncol. 2022 Jan;15(1):101293. doi: 10.1016/j.tranon.2021.101293. Epub 2021 Nov 22.'}, {'pmid': '34070751', 'type': 'RESULT', 'citation': 'Baratto L, Toriihara A, Hatami N, Aparici CM, Davidzon G, Levin CS, Iagaru A. Results of a Prospective Trial to Compare 68Ga-DOTA-TATE with SiPM-Based PET/CT vs. Conventional PET/CT in Patients with Neuroendocrine Tumors. Diagnostics (Basel). 2021 May 30;11(6):992. doi: 10.3390/diagnostics11060992.'}]}, 'descriptionModule': {'briefSummary': 'The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis.', 'detailedDescription': 'There will be a single injection of the PET radiopharmaceutical followed by a standard PET/CT scan and immediately after by the digital PET/CT scan, or vice versa. The investigators wish to determine if image quality is equivalent with the digital PET/CT scanner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is ≥ 18 years old at the time of the scan\n* Patient provides written informed consent\n* Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT\n* Patient is capable of complying with study procedures\n* Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)\n\nExclusion Criteria:\n\n* Patient is pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT03081767', 'briefTitle': 'Standard PET/CT vs. Digital PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparison of Standard PET/CT vs. Digital PET/CT', 'orgStudyIdInfo': {'id': 'IRB Protocol: 39329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients undergoing digital PET/CT', 'description': 'Single arm prospective study of paired imaging studies. Patients who are referred to Nuclear Medicine and are scheduled to undergo imaging on the standard PET/CT will also have imaging performed on the digital PET/CT.', 'interventionNames': ['Diagnostic Test: Digital PET/CT scan']}], 'interventions': [{'name': 'Digital PET/CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Division of Nuclear Medicine and Molecular Imaging at Stanford has installed the first ever GE-made digital PET/CT scanner worldwide. The investigators wish to determine if the digital PET/CT scanner offers equivalent image quality as the standard PET/CT scanner.', 'armGroupLabels': ['Patients undergoing digital PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Andrei Iagaru, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Division of Nuclear Medicine and Molecular Imaging', 'investigatorFullName': 'Andrei Iagaru', 'investigatorAffiliation': 'Stanford University'}}}}