Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing. (ARTEMIS)

Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing: the ARTEMIS Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Pulmonary Lesions (PPLs)
• Intervention / Treatment: Other: Rapid onsite evaluation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanja Antic Research coordinator; Phone Number: (615) 322-5000; Email: sanja.l.antic@vumc.org
• Study Contact Backup: Name: Rafael Paez Co-PI, MD; Phone Number: (615) 322-5000; Email: rafael.paez@vumc.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
      • Principal Investigator: James Katsis, MD
      • Contact: Kimberly Saulsberry Research coordinator; Phone Number: 773-251-8260; Email: kimberly_p_saulsberry@rush.edu
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
      • Contact: Mary Carns Research coordinator; Phone Number: (312) 503-1137; Email: m-carns@northwestern.edu
      • Principal Investigator: Christopher Kapp, MD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
      • Contact: Jenna Loss Research coordinator; Phone Number: 410-955-5000; Email: jlos1@jhmi.edu
      • Principal Investigator: Jeffrey Thiboutot, MD
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
      • Principal Investigator: Carla Lamb, MD
      • Contact: Alyssa Marie B Loessi Research coordinator; Phone Number: 781-744-1192; Email: AlyssaMarie.Loessi@lahey.org
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
      • Principal Investigator: Lonny Yarmus, DO
      • Contact: Shanti Persuad Research coordinator; Phone Number: 332-699-7260; Email: mangarl@mskcc.org
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27154
      • University of North Carolina Medical Center
      • Principal Investigator: Jason Akulian, MD
      • Contact: Kelsey Haywood Research coordinator; Phone Number: 984-974-1000; Email: kelsey_haywood@med.unc.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
      • Principal Investigator: Christopher Gilbert, MD
      • Contact: Michael Balassone Research coordinator; Phone Number: 843-792-2300; Email: balassom@musc.edu
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
      • Contact: Sanja Antic Research coordinator; Phone Number: (615) 322-5000; Email: sanja.l.antic@vumc.org
      • Principal Investigator: Rafael Paez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 18 years of age at time of bronchoscopy
• Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Robotic assisted bronchoscopy with ROSE; Participants allocated to the robotic assisted bronchoscopy arm with rapid onsite evaluation will have ROSE available during the procedure	Other: Rapid onsite evaluation; 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
Active Comparator: Robotic assisted bronchoscopy without ROSE; Participants allocated to the robotic assisted bronchoscopy arm without rapid onsite evaluation will not have ROSE available during the procedure	Other: Rapid onsite evaluation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Malignancy; Specific benign pathologic findings including: organizing pneumonia, frank purulence/robust 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sufficiency of malignant specimens for Next-Generation Sequencing	Proportion of malignant biopsies with sufficient material to send for NGS	30 days post procedure

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Fabien Maldonado, MD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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/American College of Chest Physicians Research Statement. Am J Respir Crit Care Med. 2024 Mar 15;209(6):634-646. doi: 10.1164/rccm.202401-0192ST.
• 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/rccm.202409-1846OC.
• 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/cncy.22641. Epub 2022 Sep 1.
• 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/NEJMoa2414059. Epub 2025 May 18.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Peripheral pulmonary lesion; Robotic assisted bronchoscopy; Rapid onsite evaluation
• Other Study ID Numbers: 260528

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported will be made available after de-identification.
• IPD Sharing Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 3 years.
• IPD Sharing Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes