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

ClinicalTrials.gov ID

NCT07685977

Lead Sponsor

Vanderbilt University Medical CenterOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

400Estimated

Last Update Posted

Jul 6, 2026Actual

Start Date

Oct 1, 2026Estimated

Primary Completion Date

Apr 1, 2028Estimated

Completion Date

Apr 1, 2029Estimated

Official Title

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

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.

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.

• Peripheral Pulmonary Lesions (PPLs)

• Rapid onsite evaluation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Vanderbilt University Medical CenterOTHER

Collaborators

AstraZenecaINDUSTRY

kimberly_p_saulsberry@rush.edu773-251-8260

jlos1@jhmi.edu410-955-5000

AlyssaMarie.Loessi@lahey.org781-744-1192

mangarl@mskcc.org332-699-7260

kelsey_haywood@med.unc.edu984-974-1000

balassom@musc.edu843-792-2300

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

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