Peripheral Pulmonary Lesions (PPLs)ARTEMISNCT07685977
Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing.
A study testing Rapid onsite evaluation in people with Peripheral Pulmonary Lesions (PPLs), run by Vanderbilt University Medical Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Lesions (PPLs)
- What is being tested?
- Rapid onsite evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Oct 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at time of bronchoscopy
- Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Jenna Loss Research coordinator, 410-955-5000, jlos1@jhmi.edu
Jeffrey Thiboutot, MD
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Alyssa Marie B Loessi Research coordinator, 781-744-1192, AlyssaMarie.Loessi@lahey.org
Carla Lamb, MD
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27154
Kelsey Haywood Research coordinator, 984-974-1000, kelsey_haywood@med.unc.edu
Jason Akulian, MD
Medical University of South Carolina
Charleston, South Carolina, 29425
Michael Balassone Research coordinator, 843-792-2300, balassom@musc.edu
Christopher Gilbert, MD
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Mary Carns Research coordinator, (312) 503-1137, m-carns@northwestern.edu
Christopher Kapp, MD
Rush University Medical Center
Chicago, Illinois, 60612
Kimberly Saulsberry Research coordinator, 773-251-8260, kimberly_p_saulsberry@rush.edu
James Katsis, MD
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Sanja Antic Research coordinator, (615) 322-5000, sanja.l.antic@vumc.org
Rafael Paez, MD
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Shanti Persuad Research coordinator, 332-699-7260, mangarl@mskcc.org
Lonny Yarmus, DO
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Pulmonary Lesions (PPLs)
- Being tested
- Rapid onsite evaluation
- Keywords
- Peripheral pulmonary lesion, Robotic assisted bronchoscopy, Rapid onsite evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid onsite evaluationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Rapid onsite evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days post procedure
Secondary outcomes (1)
Sufficiency of malignant specimens for Next-Generation Sequencing
Proportion of malignant biopsies with sufficient material to send for NGS
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Pulmonary Lesions (PPLs)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a pragmatic randomized controlled trial with parallel group assignment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Rafael Paez, Vanderbilt University Medical Center
- Investigators
- Fabien Maldonado, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685977
- Sponsor's protocol ID
- 260528
- Acronym
- ARTEMIS
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be made available after de-identification.
Publications
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.
PubMed 40460390Avasarala 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.
PubMed 36048711Gonzalez 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.
PubMed 38394646Lentz 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.
PubMed 40387025
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing: the ARTEMIS Trial.
- ClinicalTrials.gov ID
- NCT07685977
- Acronym / sponsor ID
- ARTEMIS / 260528
- Conditions
- Peripheral Pulmonary Lesions (PPLs)
- Keywords
- Peripheral pulmonary lesion, Robotic assisted bronchoscopy, Rapid onsite evaluation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a pragmatic randomized controlled trial with parallel group assignment.
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted bronchoscopy with ROSE | Active comparator | Other: Rapid onsite evaluationParticipants allocated to the robotic assisted bronchoscopy arm with rapid onsite evaluation will have ROSE available during the procedure |
| Robotic assisted bronchoscopy without ROSE | Active comparator | Other: Rapid onsite evaluationParticipants allocated to the robotic assisted bronchoscopy arm without rapid onsite evaluation will not have ROSE available during the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years of age at time of bronchoscopy
- Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid onsite evaluationROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy | Other | Robotic assisted bronchoscopy with ROSE, Robotic assisted bronchoscopy without ROSE |
Primary outcome
Strict diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
Time frame: 7 days post procedure
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.
1 secondary outcome
Sufficiency of malignant specimens for Next-Generation Sequencing
Time frame: 30 days post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 40460390Paez 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.
- Background: PubMed 36048711Avasarala 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.
- Background: PubMed 38394646Gonzalez 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.
- Background: PubMed 40387025Lentz 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be made available after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabien Maldonado, MD principal investigator
Vanderbilt University Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid onsite evaluation in people with Peripheral Pulmonary Lesions (PPLs), run by Vanderbilt University Medical Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanja Antic Research coordinator ((615) 322-5000, sanja.l.antic@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strict diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue. (time frame: 7 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07685977, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.