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

NCT07685977 | Not Yet Recruiting DMC

• 1 other identifier: 260528
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Peripheral Pulmonary Lesions (PPLs)

Keywords

Peripheral pulmonary lesion; Robotic assisted bronchoscopy; Rapid onsite evaluation

Outcome Measures

Primary Outcomes (1)

• 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: 1. Malignancy 2. 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 Outcomes (1)

• Sufficiency of malignant specimens for Next-Generation Sequencing

  30 days post procedure

Study Arms (2)

Robotic assisted bronchoscopy with ROSE

ACTIVE COMPARATOR

Participants allocated to the robotic assisted bronchoscopy arm with rapid onsite evaluation will have ROSE available during the procedure

Other: Rapid onsite evaluation

Robotic assisted bronchoscopy without ROSE

ACTIVE COMPARATOR

Participants allocated to the robotic assisted bronchoscopy arm without rapid onsite evaluation will not have ROSE available during the procedure

Other: Rapid onsite evaluation

Interventions

Rapid onsite evaluation OTHER

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

Robotic assisted bronchoscopy with ROSE; Robotic assisted bronchoscopy without ROSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: collaborator
• Vanderbilt University Medical Center: lead

Study Sites (8)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27154, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (4)

• 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.

  PMID: 40460390 BACKGROUND

• 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.

  PMID: 36048711 BACKGROUND

• 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.

  PMID: 38394646 BACKGROUND

• 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.

  PMID: 40387025 BACKGROUND

Study Officials

• Fabien Maldonado, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanja Antic Research coordinator

CONTACT

(615) 322-5000; sanja.l.antic@vumc.org

Rafael Paez Co-PI, MD

CONTACT

(615) 322-5000; rafael.paez@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: It is not possible to blind the bronchoscopist given the nature of the intervention. However, patients and thoracic pathologists (outcome adjudicators) will remain blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: This study is a pragmatic randomized controlled trial with parallel group assignment.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 3 years.
• 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.

Locations

US (8)