Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-17 @ 1:21 PM
Study NCT ID:
NCT06427369
Status:
WITHDRAWN
Last Update Posted:
2024-09-27
First Post:
2024-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'prioritization', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of grade 3+ I-hJAA-F11 related adverse events', 'timeFrame': 'Up to 6 months after final PET/CT', 'description': 'Incidence of severe adverse events will be graded according to CTCAE ver 5'}, {'measure': 'Evaluate Diagnostic efficacy of I-hJAA-F11', 'timeFrame': 'Within 30 days of final I/hJAA-f11 PET/CT', 'description': 'uptake values for tumor and normal organs will be measured and tumor to normal orgrans background ratios will be obtained.'}], 'secondaryOutcomes': [{'measure': 'Development of anti-drug antibodies', 'timeFrame': 'Up to approximately 8 weeks'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extensive-stage Small-cell Lung Cancer', 'Limited-stage Small-cell Lung Cancer', 'Lung Non-Small Cell Carcinoma', 'Stage IIIA Lung Cancer', 'Stage IV Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This phase I trial studies the side effects of 124I-hJAA-F11, and evaluates how well it works in diagnosing lung cancer. 124I-hJAA-F11 uses a known radioactive substance used in imaging called iodine 124 (124I). hJAA-F11 is an experimental (investigational) antibody that is currently being evaluated as a potential treatment for lung cancer. In animal studies, hJAA-F11 has shown anti-tumor activity against tumors bearing the Thomsen-Friedenreich antigen that is found in over 90% of lung cancers. 124I-hJAA-F11 has the 124I radioactive dye attached to this investigational antibody, which may be a potential tool for imaging-based diagnosis of lung cancer.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and diagnostic efficacy of 124I-hJAA-F11 in detecting lung cancer.\n\nSECONDARY OBJECTIVES:\n\nI. To assess the development of anti-drug antibodies following administration of 124I-hJAAF11.\n\nII. To characterize concordance in lesions characterized by 124I-hJAA-F11-based positron emission tomography/computed tomography (PET/CT) compared to standard of care FDG (fluorodeoxyglucose)-PET.\n\nIII. To perform exploratory biomarker analyses based on conventional tissue and liquid-based platforms.\n\nOUTLINE:\n\nPatients receive 124I-hJAA-F11 intravenously (IV) on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial.\n\nAfter completion of the study intervention, patients are followed up at day 8-14, weeks 4 and 8, and at 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically or cytologically diagnosed small cell lung cancer (SCLC; either extensive stage or limited stage) or non-small cell lung cancer (NSCLC; at least clinical stage IIIA according to the American Joint Cancer Committee \\[AJCC\\] 8th edition)\n* Patients undergoing FDG-PET scan as standard of care testing.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection (exceptions allowed include patients on chronic antiviral or anti-bacterial medications without acute flares in the preceding 2 weeks), symptomatic congestive heart failure, unstable angina pectoris, Child-Pugh class C, dialysis-dependence, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Pregnant or nursing female participants'}, 'identificationModule': {'nctId': 'NCT06427369', 'briefTitle': 'An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11', 'orgStudyIdInfo': {'id': 'I -1774023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic', 'description': 'Patients receive 124I-hJAA-F11 IV on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial.', 'interventionNames': ['Other: Radioconjugate', 'Procedure: Positron Emission Tomography', 'Procedure: Computed Tomography', 'Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan', 'Procedure: Biospecimen Collection']}], 'interventions': [{'name': 'Radioconjugate', 'type': 'OTHER', 'description': '1241-hJAA-F11 IV administration', 'armGroupLabels': ['Diagnostic']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['PET', 'PET SCAN'], 'description': 'PET/CT Imaging', 'armGroupLabels': ['Diagnostic']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan'], 'description': 'PET/CT Imaging', 'armGroupLabels': ['Diagnostic']}, {'name': 'FDG-Positron Emission Tomography and Computed Tomography Scan', 'type': 'PROCEDURE', 'otherNames': ['FDG PET/CT'], 'description': 'FDG PET/CT Imaging', 'armGroupLabels': ['Diagnostic']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection'], 'description': 'Blood sample collection imaging', 'armGroupLabels': ['Diagnostic']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Grace Dy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}