[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07685977":3,"trial-entities:NCT07685977":206,"trial-summary:NCT07685977":210},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":62,"locations":65,"central_contacts":183,"overall_officials":188,"references":191,"see_also_links":205},"NCT07685977","260528","Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing.","Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing: the ARTEMIS Trial.","NOT_YET_RECRUITING","2029-04-01","2026-06","2026-07-06","2026-10-01","Vanderbilt University Medical Center","OTHER",true,"ARTEMIS is a multicenter randomized controlled trial. The goal is to understand whether rapid onsite evaluation during robotic assisted bronchoscopy improves the diagnostic performance of the procedure or not.","Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. Robotic assisted bronchoscopy (RAB) with integrated cone beam computed tomography (CBCT) has achieved diagnostic yields exceeding 80% in some studies, significantly higher than traditional methods without advanced imaging, due to the added ability to correct alignment of the bronchoscopy catheter with the target lesion in real-time. Given this, the added value of rapid on-site cytologic evaluation (ROSE) with modern bronchoscopy is an area of debate. ROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy. This study will aim to test the hypothesis that modern bronchoscopy done without ROSE guidance is non-inferior to bronchoscopy with ROSE available. Patients undergoing RAB to biopsy a lung lesion will be approached for enrollment and assigned to either ROSE vs no ROSE if they agree to participate. Randomization will be revealed before procedures are started. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.",[19],"Peripheral Pulmonary Lesions (PPLs)",[21,22,23],"Peripheral pulmonary lesion","Robotic assisted bronchoscopy","Rapid onsite evaluation","INTERVENTIONAL","DIAGNOSTIC",[27],"NA",{"count":29,"type":30},400,"ESTIMATED",[32],{"type":14,"name":23,"description":33,"armGroupLabels":34},"ROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy",[35,36],"Robotic assisted bronchoscopy with ROSE","Robotic assisted bronchoscopy without ROSE",[38],{"measure":39,"description":40,"timeFrame":41},"Strict diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.","Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified:\n\n1. Malignancy\n2. Specific benign pathologic findings including: organizing pneumonia, frank purulence\u002Frobust neutrophilic inflammation with a pathogen isolated, granulomatous inflammation, hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns.","7 days post procedure",[43],{"measure":44,"description":45,"timeFrame":46},"Sufficiency of malignant specimens for Next-Generation Sequencing","Proportion of malignant biopsies with sufficient material to send for NGS","30 days post procedure","ALL","18 Years",null,false,{"inclusion":52,"exclusion":55,"raw_text":61},[53,54],"≥ 18 years of age at time of bronchoscopy","Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion",[56,57,58,59,60],"Declines to participate or inability to provide informed consent.","Clinician determination that the use of ROSE is required or contraindicated for the optimal care of an individual patient","Patient enrolled in another trial that requires ROSE for PPL biopsy","Patient previously consented for this trial","Pregnant or incarcerated patients","Inclusion Criteria:\n\n* ≥ 18 years of age at time of bronchoscopy\n* Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion\n\nExclusion Criteria:\n\n* Declines to participate or inability to provide informed consent.\n* Clinician determination that the use of ROSE is required or contraindicated for the optimal care of an individual patient\n* Patient enrolled in another trial that requires ROSE for PPL biopsy\n* Patient previously consented for this trial\n* Pregnant or incarcerated patients",[63,64],"ADULT","OLDER_ADULT",[66,84,95,110,125,139,154,169],{"facility":67,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":81},"Northwestern Memorial Hospital","Chicago","Illinois","60611","United States",[73,78],{"name":74,"role":75,"phone":76,"email":77},"Mary Carns Research coordinator","CONTACT","(312) 503-1137","m-carns@northwestern.edu",{"name":79,"role":80},"Christopher Kapp, MD","PRINCIPAL_INVESTIGATOR",{"lat":82,"lon":83},41.85003,-87.65005,{"facility":85,"city":68,"state":69,"zip":86,"country":71,"contacts":87,"geoPoint":94},"Rush University Medical Center","60612",[88,92],{"name":89,"role":75,"phone":90,"email":91},"Kimberly Saulsberry Research coordinator","773-251-8260","kimberly_p_saulsberry@rush.edu",{"name":93,"role":80},"James Katsis, MD",{"lat":82,"lon":83},{"facility":96,"city":97,"state":98,"zip":99,"country":71,"contacts":100,"geoPoint":107},"Johns Hopkins University","Baltimore","Maryland","21287",[101,105],{"name":102,"role":75,"phone":103,"email":104},"Jenna Loss Research coordinator","410-955-5000","jlos1@jhmi.edu",{"name":106,"role":80},"Jeffrey Thiboutot, MD",{"lat":108,"lon":109},39.29038,-76.61219,{"facility":111,"city":112,"state":113,"zip":114,"country":71,"contacts":115,"geoPoint":122},"Lahey Hospital and Medical Center","Burlington","Massachusetts","01805",[116,120],{"name":117,"role":75,"phone":118,"email":119},"Alyssa Marie B Loessi Research coordinator","781-744-1192","AlyssaMarie.Loessi@lahey.org",{"name":121,"role":80},"Carla Lamb, MD",{"lat":123,"lon":124},42.50482,-71.19561,{"facility":126,"city":127,"state":127,"zip":128,"country":71,"contacts":129,"geoPoint":136},"Memorial Sloan Kettering Cancer Center","New York","10065",[130,134],{"name":131,"role":75,"phone":132,"email":133},"Shanti Persuad Research coordinator","332-699-7260","mangarl@mskcc.org",{"name":135,"role":80},"Lonny Yarmus, DO",{"lat":137,"lon":138},40.71427,-74.00597,{"facility":140,"city":141,"state":142,"zip":143,"country":71,"contacts":144,"geoPoint":151},"University of North Carolina Medical Center","Chapel Hill","North Carolina","27154",[145,149],{"name":146,"role":75,"phone":147,"email":148},"Kelsey Haywood Research coordinator","984-974-1000","kelsey_haywood@med.unc.edu",{"name":150,"role":80},"Jason Akulian, MD",{"lat":152,"lon":153},35.9132,-79.05584,{"facility":155,"city":156,"state":157,"zip":158,"country":71,"contacts":159,"geoPoint":166},"Medical University of South Carolina","Charleston","South Carolina","29425",[160,164],{"name":161,"role":75,"phone":162,"email":163},"Michael Balassone Research coordinator","843-792-2300","balassom@musc.edu",{"name":165,"role":80},"Christopher Gilbert, MD",{"lat":167,"lon":168},32.77632,-79.93275,{"facility":13,"city":170,"state":171,"zip":172,"country":71,"contacts":173,"geoPoint":180},"Nashville","Tennessee","37232",[174,178],{"name":175,"role":75,"phone":176,"email":177},"Sanja Antic Research coordinator","(615) 322-5000","sanja.l.antic@vumc.org",{"name":179,"role":80},"Rafael Paez, MD",{"lat":181,"lon":182},36.16589,-86.78444,[184,185],{"name":175,"role":75,"phone":176,"email":177},{"name":186,"role":75,"phone":176,"email":187},"Rafael Paez Co-PI, MD","rafael.paez@vumc.org",[189],{"name":190,"affiliation":13,"role":80},"Fabien Maldonado, MD",[192,196,199,202],{"pmid":193,"type":194,"citation":195},"40460390","BACKGROUND","Paez R, Lentz RJ, Duke JD, Siemann JK, Salmon C, Dahlberg GJ, Ratwani AP, Casey JD, Chen H, Chen SC, Shojaee S, Rickman OB, Gatto CL, Rice TW, Maldonado F. Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT). Am J Respir Crit Care Med. 2025 Sep;211(9):1644-1651. doi: 10.1164\u002Frccm.202409-1846OC.",{"pmid":197,"type":194,"citation":198},"36048711","Avasarala SK, Matta M, Singh J, Bomeisl P, Michael CW, Young B, Panchabhai TS, Di Felice C, Dahlberg G, Maldonado F. Rapid On-site Evaluation Practice Variability Appraisal (ROSE PETAL) survey. Cancer Cytopathol. 2023 Feb;131(2):90-99. doi: 10.1002\u002Fcncy.22641. Epub 2022 Sep 1.",{"pmid":200,"type":194,"citation":201},"38394646","Gonzalez AV, Silvestri GA, Korevaar DA, Gesthalter YB, Almeida ND, Chen A, Gilbert CR, Illei PB, Navani N, Pasquinelli MM, Pastis NJ, Sears CR, Shojaee S, Solomon SB, Steinfort DP, Maldonado F, Rivera MP, Yarmus LB. Assessment of Advanced Diagnostic Bronchoscopy Outcomes for Peripheral Lung Lesions: A Delphi Consensus Definition of Diagnostic Yield and Recommendations for Patient-centered Study Designs. An Official American Thoracic Society\u002FAmerican College of Chest Physicians Research Statement. Am J Respir Crit Care Med. 2024 Mar 15;209(6):634-646. doi: 10.1164\u002Frccm.202401-0192ST.",{"pmid":203,"type":194,"citation":204},"40387025","Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Avasarala SK, Casey JD, Cheng GZ, D'Haese PF, Duke JD, Grogan EL, Hoopman TC, Johnson J, Katsis JM, Kurman JS, Low SW, Mahmood K, Rickman OB, Roller L, Salmon C, Shojaee S, Swanner B, Wahidi MM, Walston C, Silvestri GA, Yarmus L, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules. N Engl J Med. 2025 Jun 5;392(21):2100-2112. doi: 10.1056\u002FNEJMoa2414059. Epub 2025 May 18.",[],{"nct_id":4,"conditions":207,"biomarkers":209},[208],"Peripheral Pulmonary Nodule",[],{"nct_id":4,"found":15,"summary":211,"prompt_version":221},{"design":212,"status":213,"heading":214,"summary":215,"follow_up":216,"word_count":217,"commitments":218,"compensation":219,"drugs_mentioned":220},"This is a multicenter randomized controlled trial with a planned enrollment of 400 participants. Participants will be assigned to either receive rapid onsite evaluation (ROSE) or not receive ROSE during their procedure.","completed","Advanced Robotic Techniques for Lung Lesion Diagnosis","This study, called ARTEMIS, is looking at how well robotic-assisted bronchoscopy (a procedure using a thin tube with a camera to look inside your lungs) works to diagnose peripheral pulmonary lesions (PPLs), which are growths in the outer parts of your lungs. Researchers want to see if adding rapid onsite evaluation (ROSE), where biopsy samples are checked immediately during the procedure, improves diagnosis. You could join if you are 18 or older and are having a robotic-assisted bronchoscopy to biopsy a lung lesion. The study will measure how often enough tissue is collected for diagnosis within 7 days after the procedure. The current status of this study is unclear.","The primary outcome is measured 7 days after the procedure.",109,"You will undergo a robotic-assisted bronchoscopy to biopsy a lung lesion. All decisions about the procedure and your care will be made by your treating physician.","Not stated in the trial record.",[23],"v2"]