[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524213":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":68,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":27,"enrollmentInfo":89,"targetDuration":27,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":27,"overallStatus":49,"whyStopped":27,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Vanderbilt-Ingram Cancer Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"EBUS-TBNA Group","ACTIVE_COMPARATOR","The same needle gauge will be used for these participant to acquire the initial diagnosis on ROSE (either 21 or 22G). Using standard sampling techniques, the mass or LN will be penetrated with the needle as confirmed by ultrasound, and the needle will be passed back from the proximal to the distal ends of the node to obtain the samples for an adequate cell block.",[13,14],"Procedure: Endobronchial ultrasound with transbronchial needle aspiration","Procedure: Bronchoscopy",{"label":16,"type":17,"description":18,"interventionNames":19},"Transbronchial Mediastinal Cryobiopsy Group","EXPERIMENTAL","The operator will switch to a flexible, single-use, 1.1 mm cryoprobe (Erbe 20402-401, Erbe, Tübingen, Germany) for these participants to obtain cryobiopsies. The operator will introduce the probe into the working channel of the EBUS bronchoscope. The cryoprobe will then be advanced toward the puncture site and inserted gently through the previous puncture site created by the initial EBUS-TBNA needle. The operator will confirm the placement of the probe via the EBUS image, and photo capture will be done. The cryo-probe will be activated and cooled for 3 seconds before retracting with the bronchoscope with the frozen biopsy tissue attached to the tip.",[13,14,20],"Procedure: Cryobiopsy",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Endobronchial ultrasound with transbronchial needle aspiration","Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration",[9,16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Bronchoscopy","Participants will undergo Bronchoscopy",[9,16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Cryobiopsy","Participants will undergo Cryobiopsy",[16],[37],{"name":38,"affiliation":39,"role":40},"Fabien Maldonado, MD","Vanderbilt University\u002FIngram Cancer Center","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Vanderbilt-Ingram Services for Timely Access","CONTACT","800-811-8480","cip@vumc.org",[48],{"facility":39,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-86.78444,36.16589,{"lat":59,"lon":58},[62,64],{"name":63,"role":44,"phone":45,"phoneExt":27,"email":46},"Vanderbilt-Ingram Service Services for Timely Access",{"name":38,"role":40,"phone":27,"phoneExt":27,"email":27},{"type":40,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Fabien Maldonado","Professor of Medicine",[69,71,73,75,77],{"name":70,"class":6},"Northwestern Medicine",{"name":72,"class":6},"Johns Hopkins University",{"name":74,"class":6},"Duke University",{"name":76,"class":6},"Medical University of South Carolina",{"name":78,"class":6},"Virginia Commonwealth University","100524213","phase-4-ebus-tbna-vs-transbronchial-mediastinal-cryobiopsy-for-adequacy-of-next-generation-sequencing-100524213",false,"NCT06105801","EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing","A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing","FROSTBITE-3","Inclusion Criteria:\n\n* Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS\n* Malignant cells present on rapid on-site cytological evaluation (ROSE)\n\nExclusion Criteria:\n\n* Patient is known to be less than 18 years old\n* Patient is known to be pregnant\n* Patient is known to be a prisoner\n* Operator deems lesion is not safe to biopsy","ALL","18 Years",{"count":90,"type":91},250,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","This is a multi-center clinical trial evaluating the effect of transbronchial mediastinal cryobiopsy for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. Patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or tissue acquisition for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a sampling.",[97],"Lung Cancer","2026-01-29",{"date":100,"type":101},"2026-02-02","ACTUAL",{"date":103,"type":101},"2024-09-13",{"date":105,"type":91},"2028-10-31",{"name":5,"class":6},1]