Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT03519659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}], 'ancestors': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-22', 'size': 413486, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-22T15:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-05-07', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality', 'timeFrame': 'through study completion, on average 2-5 years', 'description': 'assessed by blinded readers'}], 'secondaryOutcomes': [{'measure': 'Artifacts', 'timeFrame': 'through study completion, on average 2-5 years', 'description': 'assessed by blinded readers'}, {'measure': 'Lesion detectability', 'timeFrame': 'through study completion, on average 2-5 years', 'description': 'assessed by blinded readers'}, {'measure': 'Image noise', 'timeFrame': 'through study completion, on average 2-5 years', 'description': 'assessed by blinded readers'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['PET/CT Imaging']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other.', 'detailedDescription': 'Positron Emission Tomography/Computed Tomography (PET/CT) imaging using 18F-FDG is an important, commonly used cancer, neuroscience and cardio-vascular imaging methodology to detect disease and to monitor therapeutic interventions. While considerable technological progress of PET/CT systems has occurred over the last decade, we have not re-evaluated the ability to potentially reduce the radiation burden of the used PET imaging pharmaceutical (FDG).\n\nThis early phase trial intends to accomplish the following:\n\n* to validate that the radiation dose burden from the PET imaging pharmaceutical (FDG) can be reduced by more than 50% from the current standard of clinical care (SOC) level without affecting the diagnostic ability;\n* to confirm that a low dose approach will be feasible for response assessment;\n* to validate that the difference in FDG uptake between imaging 60 min +/- 10 min post injection and 75 min +/- 10 min post injection is independent/equivalent of the injected FDG dose\n* to validate a simulation methodology to streamline future dose finding studies for PET imaging pharmaceuticals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients greater than or equal to 18 years of age\n* Patients scheduled for a standard of care PET/CT scan\n* For female patients of child-bearing potential, the OSUWMC requirements for receiving the standard of care PET imaging agent and CT examination needs to be met\n\nExclusion Criteria:\n\n* Participants who are pregnant or lactating\n* Prisoners\n* Participants incapable of giving informed consent\n* Patients unable to lie flat on the scanner for extended periods of time'}, 'identificationModule': {'nctId': 'NCT03519659', 'briefTitle': 'Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT', 'orgStudyIdInfo': {'id': 'RP0308/2014H0437'}, 'secondaryIdInfos': [{'id': 'R01CA195513', 'link': 'https://reporter.nih.gov/quickSearch/R01CA195513', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sub-Study A', 'description': 'Patients receive PET/CT scan on Gemini Astonish PET/CT', 'interventionNames': ['Diagnostic Test: PET/CT scan with 13 mCi radiation dose', 'Diagnostic Test: PET/CT scan with 5 mCi radiation dose']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-Study B', 'description': 'Patients receive PET/CT scan on Biograph mCT', 'interventionNames': ['Diagnostic Test: PET/CT scan with 13 mCi radiation dose', 'Diagnostic Test: PET/CT scan with 5 mCi radiation dose']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-Study C', 'description': 'Patients receive PET/CT scan on Discovery PET/CT', 'interventionNames': ['Diagnostic Test: PET/CT scan with 13 mCi radiation dose', 'Diagnostic Test: PET/CT scan with 5 mCi radiation dose']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-Study D', 'description': 'Patients receive PET/CT scan on Vereos 128 digital PET/CT', 'interventionNames': ['Diagnostic Test: PET/CT scan with 13 mCi radiation dose', 'Diagnostic Test: PET/CT scan with 5 mCi radiation dose']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-Study E', 'description': 'Patients receive lower radiation dose on Vereos 128 digital PET/CT', 'interventionNames': ['Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose', 'Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dose']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-Study F', 'description': 'Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C', 'interventionNames': ['Diagnostic Test: PET/CT scan with 13 mCi radiation dose', 'Diagnostic Test: PET/CT Scan with not yet determined radiation dose']}], 'interventions': [{'name': 'PET/CT scan with 13 mCi radiation dose', 'type': 'DIAGNOSTIC_TEST', 'description': '13 mCi 18F-FDG dose', 'armGroupLabels': ['Sub-Study A', 'Sub-Study B', 'Sub-Study C', 'Sub-Study D', 'Sub-Study F']}, {'name': 'PET/CT scan with 5 mCi radiation dose', 'type': 'DIAGNOSTIC_TEST', 'description': '5 mCi 18F-FDG dose', 'armGroupLabels': ['Sub-Study A', 'Sub-Study B', 'Sub-Study C', 'Sub-Study D']}, {'name': 'PET/CT scan with 2.5 mCi radiation dose', 'type': 'DIAGNOSTIC_TEST', 'description': '2.5 mCi 18F-FDG dose', 'armGroupLabels': ['Sub-Study E']}, {'name': 'PET/CT Scan with 6.5 mCi radiation dose', 'type': 'DIAGNOSTIC_TEST', 'description': '6.5 mCi 18F-FDG dose', 'armGroupLabels': ['Sub-Study E']}, {'name': 'PET/CT Scan with not yet determined radiation dose', 'type': 'DIAGNOSTIC_TEST', 'description': 'We plan for the possibility that one of the three-Sub-Studies (A-B) would not demonstrate equivalency, and we would then perform a modified protocol in which the SOC dosing is compared to a lower and higher dose than originally tested.', 'armGroupLabels': ['Sub-Study F']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Michael V Knopp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Ohio Third Frontier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael V Knopp MD PhD', 'investigatorAffiliation': 'University of Cincinnati'}}}}