Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-24 @ 4:33 PM
Study NCT ID:
NCT03142204
Status:
UNKNOWN
Last Update Posted:
2022-12-05
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[18F]FAraG PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy and/or Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-01', 'studyFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy', 'timeFrame': 'Up to 6 weeks before immunotherapy is administered', 'description': 'Whole-body \\[18F\\]F-AraG PET scan will be performed after intravenous injection of the PET tracer.consecutive time points the day of the intravenous injection of the PET tracer.'}, {'measure': 'Visualize biodistribution of the PET tracer [18F]F-AraG post start of immunotherapy', 'timeFrame': 'Up to 12 weeks after start of immunotherapy', 'description': 'Whole-body \\[18F\\]F-AraG PET scan will be performed after intravenous injection of the PET tracer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 study is to visualize biodistribution of a PET tracer called \\[18F\\]F-AraG (VisAcT) in cancer patients expected to undergo immunotherapy and/or radiation therapy.', 'detailedDescription': 'This is an exploratory Phase 1, prospective study assessing the biodistribution and radiation dosimetry of the Positron Emission Tomography \\[18F\\]FAraG (VisAcT) in cancer patients selected for immunotherapy and/or radiation therapy. Each patient may have up to two \\[ 18F\\]FAraG PET imaging sessions, a baseline scan and a post start of immunotherapy scan. For each imaging session, patients will receive a single injection of \\[18F\\]FAraG and undergo a whole-body PET scans an hour after injection of the tracer. Following each imaging session, the patient will be called within 72 hours to note any side effects.\n\nOptional - Blood samples may be collected at up to 9 time points post-injection to analyze whole-blood/plasma time activity of \\[18F\\]FAraG in addition an urine sample may be collected post scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer patients with identified tumor mass\n* Cancer patients expected to undergo immunotherapy and/or radiation therapy\n\nExclusion Criteria:\n\n* Under the age of 18\n* Pregnant women\n* Women who are breastfeeding\n* Individuals with known or suspected substance abuse\n* Individuals unable or unwilling to comply with the study procedures'}, 'identificationModule': {'nctId': 'NCT03142204', 'briefTitle': '[18F]FAraG PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy and/or Radiation Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'CellSight Technologies, Inc.'}, 'officialTitle': 'Study of the Kinetics, Dosimetry and Safety of [18F]F-AraG (VisAcT), a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Cancer Patients Who Have Received or Are Expected to Receive Immunotherapy and/or Radiation Therapy', 'orgStudyIdInfo': {'id': '14-14488'}}, 'armsInterventionsModule': {'interventions': [{'name': '[18F]F-AraG', 'type': 'DRUG', 'description': 'Single dose IV injection of \\[18F\\]F-AraG for each imaging day.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maya Aslam', 'role': 'CONTACT', 'email': 'maya.aslam@ucsf.edu', 'phone': '415-514-8987'}, {'name': 'Katherine Wu', 'role': 'CONTACT', 'email': 'katherine.wu@ucsf.edu', 'phone': '415-353-9437'}], 'facility': 'UCSF Imaging Center at China Basin', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Robert R Flavell, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'robert.flavell@ucsf.edu', 'phone': '917-509-8679'}, {'name': 'Henry VanBrocklin, Ph.D.', 'role': 'CONTACT', 'email': 'henry.vanbrocklin@radiology.ucsf.edu', 'phone': '415-353-4569'}], 'overallOfficials': [{'name': 'Robert R Flavell, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF Department of Radiology & Biomedical Imaging'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CellSight Technologies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UCSF Imaging Center at China Basin', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}