Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-01 @ 7:31 PM
Study NCT ID:
NCT04260256
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2020-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Using [18F]F AraG PET to Evaluate Response to Checkpoint Inhibitor Therapy(CkIT) in Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-06', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlate change in [18F]F AraG signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies', 'timeFrame': '24 Months', 'description': 'Pre and post CkIT biopsies of the same tumor lesion will be performed an analyze T-cell tumor infiltration, this will be correlated to \\[18F\\]F-AraG PET signal.'}], 'secondaryOutcomes': [{'measure': '1. Correlate change in [18F]F AraG uptake signal in tumor lesions with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) > 4 months) using iRECIST criteria', 'timeFrame': '24 Months'}, {'measure': '2. Correlate change in [18F]F AraG signal in lung and GI tract with the occurrence of Grade 3 or 4 immune related adverse events.', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Correlate Tracer Uptake to TCell Tumor Infiltration & CkIT Benefit']}, 'descriptionModule': {'briefSummary': 'In this study, patients with advanced solid tumors will undergo \\[18F\\]F AraG PET/CT imaging to assess for changes in tracer uptake following treatment with CkIT.', 'detailedDescription': 'Up to 40 patients will be recruited to participate in this study. Two (2) target lesions per patient will be selected for radiomics and biopsy. Both lesions will be assessed for \\[18F\\]F AraG uptake before and after CkIT. Only one lesion will be biopsied twice (once before and once after CkIT treatment close to the time of imaging), and the other lesion will not be manipulated and used as a control.\n\nThere will be a pre therapy scan \\[18F\\]F AraG which will be administered anytime within a 14 day period prior to the initial Day 1 CkIT administration. There will also be a post therapy scan which will be performed within 3 to 6 weeks after the initial CkIT dose. The timing of the second \\[18F\\]F AraG scans may be altered based on preliminary results from the initial patient scan results, and could be obtained during the first 2 weeks after initiation of therapy.\n\nThe investigators will compare the \\[18F\\]F AraG activity (based on development of tumoral volumes of interest (VOIs) pre and post CkIT in both lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Solid tumor with planned CkIT\n* Must be \\>18 years old\n* Signed Informed Consent Form\n* Patient must have two qualifying lesions\n\nExclusion Criteria:\n\n* Patient is pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT04260256', 'briefTitle': 'A Study Using [18F]F AraG PET to Evaluate Response to Checkpoint Inhibitor Therapy(CkIT) in Patients With Solid Tumors', 'nctIdAliases': ['NCT05219981'], 'organization': {'class': 'INDUSTRY', 'fullName': 'CellSight Technologies, Inc.'}, 'officialTitle': 'A Pilot Study of Using [18F]F AraG PET Imaging to Evaluate the Immunological Response to Checkpoint Inhibitor Therapy (CkIT) in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '53563'}}, 'armsInterventionsModule': {'interventions': [{'name': '[18F]F-AraG', 'type': 'DRUG', 'otherNames': ['VisAcT'], 'description': '\\[18F\\]F AraG injection and PET Scan Two tumor biopsies of single lesion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kavin Tamizhmani', 'role': 'CONTACT', 'email': 'ktamizhm@stanford.edu', 'phone': '650-497-6046'}, {'name': 'Carina Mari Aparici, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Libby Mirande', 'role': 'CONTACT', 'email': 'jenselib@ohsu.edu', 'phone': '503-494-4740'}, {'name': 'Erik Mittra, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'LIbby Mirande', 'role': 'CONTACT', 'email': 'jenselib@ohsu.edu', 'phone': '503 494 4740'}], 'overallOfficials': [{'name': 'Carina Mari Aparici, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Erik Mittra, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}, {'name': 'Shivaani Kummar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CellSight Technologies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}