Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
Study NCT ID:
NCT04538950
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2020-08-31
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}, {'id': 'D019275', 'term': 'Radiopharmaceuticals'}, {'id': 'D011356', 'term': 'Product Labeling'}], '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'}, {'id': 'D064907', 'term': 'Diagnostic Uses of Chemicals'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D007202', 'term': 'Indicators and Reagents'}, {'id': 'D019995', 'term': 'Laboratory Chemicals'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D019064', 'term': 'Product Packaging'}, {'id': 'D007221', 'term': 'Industry'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bois.John@mayo.edu', 'phone': '507 284-4072', 'title': 'John P. Bois, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to end of study participation for a total of approximately 6 weeks on all participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Checkpoint Inhibitor (ICI)', 'description': 'Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.\n\nPET/CT: Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.\n\nradioactive drug (tracer): A radioactive drug (tracer) is used in the PET scan.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Moderate Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Microvascular Damage/Endothelial Dysfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Checkpoint Inhibitor (ICI)', 'description': 'Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.\n\nPET/CT: Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.\n\nradioactive drug (tracer): A radioactive drug (tracer) is used in the PET scan.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Number of subjects to develop microvascular damage/endothelial dysfunction as determined by the PET/CT scan.\n\nPET-CT MFR used to assess dynamic changes in MFR that occur pre and post initiation of ICI and thereby potentially identify early cardiotoxicity in patients who might be more prone to more devastating IRAEs such as myocarditis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Checkpoint Inhibitor (ICI)', 'description': 'Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.\n\nPET/CT: Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.\n\nradioactive drug (tracer): A radioactive drug (tracer) is used in the PET scan.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Pulmonary Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Checkpoint Inhibitor (ICI)', 'description': 'Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.\n\nPET/CT: Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.\n\nradioactive drug (tracer): A radioactive drug (tracer) is used in the PET scan.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.17', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', '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': '0', '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': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-10', 'size': 299936, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-27T08:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2020-08-31', 'resultsFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2020-08-31', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-07', 'studyFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microvascular Damage/Endothelial Dysfunction', 'timeFrame': '6 weeks', 'description': 'Number of subjects to develop microvascular damage/endothelial dysfunction as determined by the PET/CT scan.\n\nPET-CT MFR used to assess dynamic changes in MFR that occur pre and post initiation of ICI and thereby potentially identify early cardiotoxicity in patients who might be more prone to more devastating IRAEs such as myocarditis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to determine the side effects on the heart from immune checkpoint inhibitor (ICI) treatment in patients with cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First time administration of ICI\n* Willing and able to return in 4-6 weeks for follow-up study\n* Patients with previous heart conditions included (while this may impact MFR the delta MFR is what we are assessing)\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Women who are pregnant, or breast-feeding.\n* Unable or unwilling to give consent to undergo PET/CT.'}, 'identificationModule': {'nctId': 'NCT04538950', 'briefTitle': 'PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy', 'orgStudyIdInfo': {'id': '19-009189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Checkpoint Inhibitor (ICI)', 'description': 'Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.', 'interventionNames': ['Diagnostic Test: PET/CT', 'Drug: radioactive drug (tracer)']}], 'interventions': [{'name': 'PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.', 'armGroupLabels': ['Checkpoint Inhibitor (ICI)']}, {'name': 'radioactive drug (tracer)', 'type': 'DRUG', 'description': 'A radioactive drug (tracer) is used in the PET scan.', 'armGroupLabels': ['Checkpoint Inhibitor (ICI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'John Bois, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'John P. Bois, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}