Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT05452005
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2022-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2022-07-06', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry', 'timeFrame': 'Up to six months', 'description': 'Standard uptake value (SUV) values from \\[18F\\]-αvβ6-BP PET/CT will be compared to immunohistochemistry (IHC) αvβ6 staining of archival tissue to assess the sensitivity of \\[18F\\]-αvβ6-BP PET/CT to detect αvβ6 positive metastasis in NSCLC'}], 'secondaryOutcomes': [{'measure': 'Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging', 'timeFrame': 'Up to six months', 'description': 'Detection of lesions with \\[18F\\]-αvβ6-BP will be compared to the number of lesions identified during standard-of-care MRI imaging'}, {'measure': 'Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging', 'timeFrame': 'Up to six months', 'description': 'SUVmax values obtained during standard-of-care FDG/PET will be compared to SUVmax values obtained from \\[18F\\]-αvβ6-BP PET/CT imaging'}, {'measure': 'Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment', 'timeFrame': 'Up to six months', 'description': 'Lesion response will be assessed based on standard-of-care MRI images, \\[18F\\]-FDG PET/CT and \\[18F\\]-αvβ6-BP PET/CT post treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positron Emission Tomography'], 'conditions': ['Lung Cancer', 'Lung Cancer Metastatic', 'Brain Metastases', 'Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study investigates fluorine-18-AlphaVBeta6-BP (\\[18F\\]-αvβ6-BP) as a Positron Emission (PET) imaging agent in Non-Small Cell Lung Cancer (NSCLC) patients with brain metastases. Investigators hypothesize that \\[18F\\]-αvβ6-BP PET/Computed Tomography (CT) is a sensitive tool for disease assessment in patients with metastatic NSCLC, including those with brain metastases.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nThe primary objective of this study is to evaluate the sensitivity and specificity of \\[18F\\]-αvβ6-BP PET/CT for detecting metastases in patients with NSCLC.\n\nOUTLINE:\n\nPatients will undergo \\[18F\\]-αvβ6-BP PET/CT at baseline in addition to standard-of-care \\[18F\\]-2-fluoro-2-deoxy-D-glucose (FDG) PET/CT body and magnetic resonance imaging (MRI) of the brain. Patients will then undergo standard-of-care cancer directed therapy. Patients will be re-staged 8-12 weeks later at the next standard-of-care imaging time point with \\[18F\\]-αvβ6-BP PET/CT, \\[18F\\]-FDG PET/CT, and MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women age \\>18 yrs\n2. Biopsy proven NSCLC with brain metastases (treated or untreated)\n3. Life-expectancy of ≥3 months in the opinion of the treating physician\n4. Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available.\n5. Able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan\n6. Ability to understand and willingness to sign a written informed consent document.\n7. Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging\n8. \\[18F\\]-FDG PET/CT within 21 days of enrollment\n9. MRI brain within 21 days of enrollment\n10. Eastern Cooperative Oncology Group Performance Status ≤ 2\n11. Glomerular filtration rate (GFR) ≥ 60\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Prisoners\n3. Concurrent malignancy of a different histology that could confound imaging interpretation\n4. Patients who cannot undergo PET/CT scanning because of weight limits(\\>350lbs)'}, 'identificationModule': {'nctId': 'NCT05452005', 'briefTitle': 'Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '1718953'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental [18F]-αvβ6-BP', 'description': 'Patients receive \\[18F\\]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.', 'interventionNames': ['Drug: [18F]-αvβ6-BP']}], 'interventions': [{'name': '[18F]-αvβ6-BP', 'type': 'DRUG', 'description': 'Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.', 'armGroupLabels': ['Experimental [18F]-αvβ6-BP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie L Sutcliffe', 'role': 'CONTACT', 'email': 'jlsutcliffe@ucdavis.edu', 'phone': '916-734-5536'}, {'name': 'Megan Daly, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The University of California Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'jlsutcliffe@ucdavis.edu', 'phone': '916-734-5536'}, {'name': 'Julie L Sutcliffe', 'role': 'CONTACT', 'email': 'jlsutcliffe@ucdavis.edu', 'phone': '9167345536'}], 'overallOfficials': [{'name': 'Julie L. Sutcliffe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Regents of the University of California (Davis)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine and Biomedical Engineering', 'investigatorFullName': 'Julie L. Sutcliffe, Ph.D', 'investigatorAffiliation': 'University of California, Davis'}}}}