[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513701":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":72,"collaborators":12,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":12,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":42,"whyStopped":12,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Abramson Cancer Center at Penn Medicine","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care (clinician assessment)","NO_INTERVENTION","In the usual care arm, clinicians will evaluate individuals with indeterminate pulmonary nodules as part of routine clinical care. No specific guidance regarding pulmonary nodule risk stratification will provided to evaluating clinicians.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Clinician assessment + CAD-based risk stratification","EXPERIMENTAL","In the experimental arm, evaluating clinicians will receive a Lung Cancer Prediction report from an artificial intelligence radiomics-based computer-aided diagnosis tool for risk stratification of pulmonary nodules.",[18],"Device: Optellum Virtual Nodule Clinic",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Optellum Virtual Nodule Clinic","The Optellum Virtual Nodule Clinic is an FDA-approved (Class II) device for risk stratification of pulmonary nodules. It uses a convolutional neural network to evaluate CT imaging data to provide an estimate of malignancy risk for indeterminate pulmonary nodules.",[14],[26],{"name":27,"affiliation":28,"role":29},"Roger Y. Kim, MD, MSCE","University of Pennsylvania","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":12,"email":34},"CONTACT","215-662-3677","roger.kim@pennmedicine.upenn.edu",{"name":36,"role":32,"phone":37,"phoneExt":12,"email":38},"Anil Vachani, MD, MSCE","215-573-7931","avachani@pennmedicine.upenn.edu",[40,57,64],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Penn Medicine University City","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-75.16362,39.95238,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":12,"phoneExt":12,"email":12},"Roger Kim, MD, MSCE",{"facility":58,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Perelman Center for Advanced Medicine",{"type":49,"coordinates":60},[51,52],{"lat":52,"lon":51},[63],{"name":56,"role":32,"phone":12,"phoneExt":12,"email":12},{"facility":65,"status":42,"city":43,"state":44,"zip":66,"country":46,"countryCode":47,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Penn Medicine Washington Square","19107",{"type":49,"coordinates":68},[51,52],{"lat":52,"lon":51},[71],{"name":56,"role":32,"phone":12,"phoneExt":12,"email":12},{"type":29,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Roger Y. Kim","Assistant Professor of Medicine","100513701","assessment-of-a-radiomics-based-computer-aided-diagnosis-tool-for-pulmonary-nodules-100513701",false,"NCT05968898","Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES","Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules","ARCADES","Inclusion Criteria:\n\n1. Male or female, aged 35-89 years\n2. Scheduled to be evaluated at a UPHS PN clinic\n3. Newly discovered solid or part-solid indeterminate PN 8-30mm in maximal diameter on CT imaging within 60 days of index clinic visit\n4. Chest CT imaging meeting the technical requirements for compatibility with Optellum Virtual Nodule Clinic software\n\nExclusion Criteria:\n\n1. Chest CT imaging with discrete mediastinal or hilar lymphadenopathy by CT size criteria (\\>10mm in maximal short-axis diameter on axial CT images)\n2. PNs with popcorn calcification (consistent with benign etiology)\n3. Pure ground-glass subsolid PNs (may be associated with lower risk of clinically significant malignancy)\n4. PN previously seen on CT imaging \\>60 days prior to most recent CT\n5. More than one indeterminate PN 8-30mm in maximal diameter\n6. History of lung cancer\n7. History of active cancer within the previous 5 years\n8. Presence of a thoracic implant that impedes PN visualization","ALL","35 Years","89 Years",{"count":87,"type":88},300,"ESTIMATED","INTERVENTIONAL",[91],"NA","This is a pragmatic clinical trial that will study the effect of a radiomics-based computer-aided diagnosis (CAD) tool on clinicians' management of pulmonary nodules (PNs) compared to usual care. Adults aged 35-89 years with 8-30mm PNs evaluated at Penn Medicine PN clinics will undergo 1:1 randomization to one of two groups, defined by the PN malignancy risk stratification strategy used by evaluating clinicians: 1) usual care or 2) usual care + use of a radiomics-based CAD tool.",[94,95],"Lung Cancer","Pulmonary Nodule, Solitary",[97,98,99,100,101],"clinical effectiveness","clinical utility","artificial intelligence","medical decision-making","risk stratification","2026-06-01",{"date":104,"type":105},"2026-06-02","ACTUAL",{"date":107,"type":105},"2024-01-09",{"date":109,"type":88},"2030-07-31",{"name":5,"class":6},3]