Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 4:46 AM
Study NCT ID:
NCT05157659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2021-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[18F]F-AraG PET Imaging to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation with immune profile of PBMCs', 'timeFrame': 'one year', 'description': 'To explore the \\[18F\\]F-AraG PET uptake in tumor, lymph nodes and spleen with the immune profile of peripheral blood mononuclear cells (PBMC).'}], 'primaryOutcomes': [{'measure': 'Full kinetic modelling', 'timeFrame': 'six months', 'description': 'To perform full kinetic modeling of \\[18F\\]F-AraG for the uptake in tumor lesions and healthy organs (e.g. spleen) by exploring different kinetic models and outcome measures as well as its test-retest (TRT) variability to guide the selection of an optimal PET pharmacokinetic model.'}, {'measure': 'Correlation with number of CD8 T-cell', 'timeFrame': 'six months', 'description': 'To correlate the relationship between the tumor uptake of \\[18F\\]F-AraG and the number of CD8 T-cells amongst others as measured by Immunohistochemistry (IHC) and gene expression.'}], 'secondaryOutcomes': [{'measure': 'Correlation with [18F]-FDG PET uptake', 'timeFrame': 'six months', 'description': 'To correlate the \\[18F\\]-FDG PET uptake with uptake derived from \\[18F\\]F-AraG PET'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positron Emission Tomography', '[18F]F-AraG', 'T-Lymphocytes', 'Kinetic Modelling', 'Reproducibility of Results'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '\\[18F\\]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the ATTAIN trial is to investigate the pharmacokinetic characteristics of this novel tracer by performing a full kinetic modelling, assess test-retest (TRT) variability and to correlate the tumor tracer uptake with the pathological assessment.', 'detailedDescription': "The efficacy of immunotherapy and patient selection for combinatorial immunotherapy strategies would greatly improve if the tumor microenvironment (TME) could be characterized more accurately. Positron emission tomography (PET) using tracers that target immune cell subsets may provide a non-invasive means to immune profile the TME. Imaging T-cells can help in identifying 'hot' tumors, or parts of the tumor mass that have high concentrations of tumor infiltrating T-cells and also provide information on its activation.\n\nA promising tracer to image activated T-cells is \\[18F\\]F-AraG. Based on the hypothesis that \\[18F\\]F-AraG will accumulate in activated T-cells, it is expected that \\[18F\\]F-AraG and PET will enable to (reproducibly) identify tumors and tumor areas with high concentrations of tumor infiltrating activated T-cells on pathological assessment. In the ATTAIN trial this \\[18F\\]F-AraG uptake in tumor lesions and healthy organs is explored by full kinetic modelling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed NSCLC, a histological biopsy is mandatory.\n2. Patients that are resectable upfront as per multidisciplinary tumor board evaluation.\n3. Be willing and able to provide written informed consent for the trial.\n4. Be above 18 years of age on day of signing informed consent.\n5. Have a performance status of 0-1 on the ECOG Performance Scale at screening.\n\nExclusion Criteria:\n\n1. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of screening. Inhaled or topical steroids, and adrenal replacement steroid \\>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n2. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n3. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last \\[18F\\]F-AraG PET scan.'}, 'identificationModule': {'nctId': 'NCT05157659', 'acronym': 'ATTAIN', 'briefTitle': '[18F]F-AraG PET Imaging to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'A Clinical Imaging Study Using [18F]F-AraG PET to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer.', 'orgStudyIdInfo': {'id': 'NL77310.029.21'}, 'secondaryIdInfos': [{'id': '2021-001489-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F]F-AraG PET procedures', 'description': 'Within one week prior to resection two \\[18F\\]F-AraG PET-scans will be performed.', 'interventionNames': ['Diagnostic Test: [18F]F-AraG PET-scan']}], 'interventions': [{'name': '[18F]F-AraG PET-scan', 'type': 'DIAGNOSTIC_TEST', 'description': '\\[18F\\]F-AraG PET scans are performed to assess the accumulation of activated T-cells in the tumour and healthy tissue.', 'armGroupLabels': ['[18F]F-AraG PET procedures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081HV', 'city': 'Amsterdam', 'state': 'Nederland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'I. Bahce, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr. I. Bahce', 'investigatorFullName': 'Idris Bahce', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}