[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651962":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":80,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lung-RADS 4 lesion on screening LDCT",null,"Adults aged 50-80 who meet 2021 USPSTF lung cancer screening criteria and have a Lung-RADS category 4 (4A, 4B, or 4X) lesion on a standard-of-care lung cancer screening low-dose chest CT. Each participant undergoes one non-contrast multiparametric chest MRI at 3.0 T for research purposes, in addition to standard of care. No standard-of-care imaging, biopsy, or treatment is withheld or replaced, and the research MRI is not used for clinical decision making. Participants continue routine clinical management; the final nature of the lesion is established from histopathology or microbiology when tissue is obtained, or otherwise from at least 24 months of clinical and imaging follow-up.",[13],"Diagnostic Test: Multiparametric chest MRI with diffusion-weighted imaging",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Multiparametric chest MRI with diffusion-weighted imaging","Single non-contrast chest MRI on a 3.0 Tesla scanner (GE Healthcare or Siemens Healthineers) with a vendor-specific surface coil. Sequences: axial breath-hold 2D in- and opposed-phase gradient echo T1-weighted imaging; axial breath-hold and\u002For respiratory-triggered multi-shot fat-suppressed EPI DWI with two b values; reduced-FOV DWI centered on the nodule; axial respiratory-triggered T2-weighted imaging with fat suppression or Dixon. Optional UTE and T1\u002FT2 mapping if time allows. No intravenous or other contrast material is administered.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Bruno Hochhegger, MD PHD","CONTACT","(352) 265-0291","bhochhegger@ufl.edu",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Julio M. F. Zhang, MD","6363513312","juliozhang107@gmail.com",[31],{"facility":32,"status":10,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"UF Health Shands Hospital","Gainesville","Florida","32610","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-82.32483,29.65163,{"lat":42,"lon":41},[45,46],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":27,"role":23,"phone":47,"phoneExt":10,"email":29},"6463513312",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100651962","multiparametric-lung-mri-with-diffusion-weighted-imaging-in-lung-rads-4-lesion-characterization-100651962",false,"NCT07768046","Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization","Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization: A Single-Center Prospective Diagnostic Accuracy Study","Inclusion Criteria:\n\n1. Age 50 to 80 years, inclusive.\n2. At least a 20 pack-year cigarette smoking history, and currently smoking or quit within the past 15 years (2021 USPSTF lung cancer screening eligibility).\n3. Underwent a standard-of-care lung cancer screening low-dose chest CT (LDCT) at the University of Florida that was assigned Lung-RADS category 4 (4A, 4B, or 4X) per ACR Lung-RADS v2022.\n4. Able to provide written informed consent independently.\n\nExclusion Criteria:\n\n1. Part-solid or cystic nodule with a solid component measuring less than 8 mm.\n2. Endobronchial nodule.\n3. MRI-incompatible or potentially MRI-incompatible implanted device.\n4. Claustrophobia that would prevent the participant from tolerating the MRI examination.\n5. Metallic device in the chest wall or spine that may interfere with adequate image acquisition in the field of view (assessed case by case).\n6. History of prior lung resection for a benign condition that may create susceptibility artifact in the field of view.\n7. Home oxygen supplementation.\n8. Active or treated lower respiratory tract infection within the prior 4 weeks.\n9. Lack of capacity to consent.","ALL","50 Years","80 Years",{"count":61,"type":62},30,"ESTIMATED","OBSERVATIONAL","This study evaluates whether multiparametric chest magnetic resonance imaging (MRI) with diffusion-weighted imaging (DWI), performed without any contrast material, can distinguish malignant from benign lung lesions that were assigned Lung-RADS category 4 on a standard-of-care lung cancer screening low-dose CT.\n\nParticipants who have a Lung-RADS 4 lesion on screening CT undergo one non-contrast research MRI of the chest at 3.0 Tesla. The MRI is added to standard care; no standard-of-care imaging, biopsy, or treatment is withheld or replaced, and the research MRI is not used for clinical decision making. Participants then continue routine clinical management, and the final nature of the lesion is established from pathology or microbiology when tissue is obtained, or otherwise from at least 24 months of clinical and imaging follow-up.\n\nThe primary measure is the sensitivity and specificity of multiparametric MRI against that final diagnosis. Secondary measures include whether DWI alone performs as well as the full MRI protocol, how MRI compares with PET\u002FCT in participants who had PET\u002FCT as part of their care, and quantitative MRI thresholds (apparent diffusion coefficient, lesion-to-spinal-cord signal intensity ratio, native T1 and T2).\n\nThis is an exploratory pilot and feasibility study. No formal power calculation was performed; the sample size is intended to support feasibility assessment, protocol optimization, and preliminary estimates of diagnostic performance.",[66,67,68,69],"Solitary Pulmonary Nodule","Multiple Pulmonary Nodules","Lung Neoplasms","Lung Cancer Screening",[71,72,73,74,75,76,77,78,79],"Lung-RADS 4","diffusion-weighted imaging","apparent diffusion coefficient","multiparametric MRI","lung cancer screening","low-dose CT","pulmonary nodule","diagnostic accuracy","non-contrast MRI","NOT_YET_RECRUITING","2026-08-17",{"date":83,"type":84},"2026-08-19","ACTUAL",{"date":86,"type":62},"2027-01",{"date":88,"type":62},"2032-01",{"name":5,"class":6},1]