Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT04376593
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-05
First Post:
2020-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET/CT Imaging in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2020-05-03', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.', 'timeFrame': 'baseline', 'description': 'Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.'}, {'measure': 'Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.', 'timeFrame': '3 months', 'description': 'Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.'}, {'measure': 'Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.', 'timeFrame': '6 months', 'description': 'Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.'}], 'primaryOutcomes': [{'measure': 'Administration of 18F-αvβ6-BP', 'timeFrame': 'baseline', 'description': 'Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients'}, {'measure': 'Administration of 18F-αvβ6-BP', 'timeFrame': '3 months', 'description': 'Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients'}, {'measure': 'Administration of 18F-αvβ6-BP', 'timeFrame': '6 months', 'description': 'Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients'}], 'secondaryOutcomes': [{'measure': 'Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage', 'timeFrame': 'baseline', 'description': 'Uptake of 18F-αvβ6-BP in lung damage will be measured by PET'}, {'measure': 'Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage', 'timeFrame': '3 months', 'description': 'Uptake of 18F-αvβ6-BP in lung damage will be measured by PET'}, {'measure': 'Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage', 'timeFrame': '6 months', 'description': 'Uptake of 18F-αvβ6-BP in lung damage will be measured by PET'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19; SARS-CoV2 infection'], 'conditions': ['COVID-19', 'SARS-CoV-2 Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://studypages.com/s/a-study-of-the-experimental-petct-radiotracer-18f-avb6-binding-peptide-after-covid-19-coronavirus-infection-935076/', 'label': 'Learn more or sign up for the study here!'}]}, 'descriptionModule': {'briefSummary': 'This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.', 'detailedDescription': 'The goal of the study is to to acquire 18F-αvβ6-BP PET/CT images in patients diagnosed with SARS CoV2 and to demonstrate the ability of 18F-αvβ6-BP to detect lung damage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women age ≥ 18 yrs\n* Diagnosed with SARS CoV2\n* Must have 2 sequential COVID negative tests prior to each scan\n* Must have no previous lung disease prior to SARS CoV2 infection\n* Lung image (Xray or CT) taken during infectious/ diagnosis period\n* Will sign the IRB-approved consent form\n* Able to remain motionless for up to 30-60 minutes per scan.\n\nExclusion Criteria:\n\n* Life expectancy \\<3 mo\n* Women who are pregnant or breast-feeding\n* Patients who cannot undergo PET/CT scanning because of weight limits(\\>350lbs)\n* Lack of availability for follow-up assessments\n* Re-infection with SARS CoV2 between scan sessions\n* Other active infectious respiratory illness'}, 'identificationModule': {'nctId': 'NCT04376593', 'briefTitle': 'PET/CT Imaging in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': '18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection', 'orgStudyIdInfo': {'id': '1592298'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-αvβ6-BP', 'description': 'Following a 10 mCi (±20%) intravenous injection (IV) of 18F-αvβ6-BP, PET/CT images will be acquired at 60 minutes. Baseline blood samples will be drawn and banked. Vital sign (VS) measurements (heart rate, respiratory rate, blood pressure and temperature) monitored throughout. Region-of-interest analysis (ROI) will be performed in the lung. Each participant will undergo up to 3 18F- αvβ6-BP PET/CT scans over a 6-month timeframe.', 'interventionNames': ['Drug: 18F-αvβ6-BP']}], 'interventions': [{'name': '18F-αvβ6-BP', 'type': 'DRUG', 'description': 'Subjects will be injected once per imaging session (a maximum of 3 imaging sessions) with up to 10 mCi (±20%) of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 secs).', 'armGroupLabels': ['18F-αvβ6-BP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Julie L. Sutcliffe, Ph.D', 'investigatorAffiliation': 'University of California, Davis'}}}}