Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing. (ARTEMIS)
2026年6月29日 更新者：Rafael Paez、Vanderbilt University Medical Center
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
400
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Sanja Antic Research coordinator
- 电话号码：(615) 322-5000
- 邮箱：sanja.l.antic@vumc.org
研究联系人备份
- 姓名：Rafael Paez Co-PI, MD
- 电话号码：(615) 322-5000
- 邮箱：rafael.paez@vumc.org
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60612
- Rush University Medical Center
-
首席研究员：
- James Katsis, MD
-
接触：
- Kimberly Saulsberry Research coordinator
- 电话号码：773-251-8260
- 邮箱：kimberly_p_saulsberry@rush.edu
-
Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
-
接触：
- Mary Carns Research coordinator
- 电话号码：(312) 503-1137
- 邮箱：m-carns@northwestern.edu
-
首席研究员：
- Christopher Kapp, MD
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- Johns Hopkins University
-
接触：
- Jenna Loss Research coordinator
- 电话号码：410-955-5000
- 邮箱：jlos1@jhmi.edu
-
首席研究员：
- Jeffrey Thiboutot, MD
-
-
Massachusetts
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Burlington、Massachusetts、美国、01805
- Lahey Hospital and Medical Center
-
首席研究员：
- Carla Lamb, MD
-
接触：
- Alyssa Marie B Loessi Research coordinator
- 电话号码：781-744-1192
- 邮箱：AlyssaMarie.Loessi@lahey.org
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-
New York
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
-
首席研究员：
- Lonny Yarmus, DO
-
接触：
- Shanti Persuad Research coordinator
- 电话号码：332-699-7260
- 邮箱：mangarl@mskcc.org
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-
North Carolina
-
Chapel Hill、North Carolina、美国、27154
- University of North Carolina Medical Center
-
首席研究员：
- Jason Akulian, MD
-
接触：
- Kelsey Haywood Research coordinator
- 电话号码：984-974-1000
- 邮箱：kelsey_haywood@med.unc.edu
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-
South Carolina
-
Charleston、South Carolina、美国、29425
- Medical University of South Carolina
-
首席研究员：
- Christopher Gilbert, MD
-
接触：
- Michael Balassone Research coordinator
- 电话号码：843-792-2300
- 邮箱：balassom@musc.edu
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-
Tennessee
-
Nashville、Tennessee、美国、37232
- Vanderbilt University Medical Center
-
接触：
- Sanja Antic Research coordinator
- 电话号码：(615) 322-5000
- 邮箱：sanja.l.antic@vumc.org
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首席研究员：
- Rafael Paez, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Robotic assisted bronchoscopy with ROSE
Participants allocated to the robotic assisted bronchoscopy arm with rapid onsite evaluation will have ROSE available during the procedure
|
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
|
|
有源比较器：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
|
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Strict diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
大体时间：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:
|
7 days post procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sufficiency of malignant specimens for Next-Generation Sequencing
大体时间：30 days post procedure
|
Proportion of malignant biopsies with sufficient material to send for NGS
|
30 days post procedure
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Fabien Maldonado, MD、Vanderbilt University Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2028年4月1日
研究完成 (估计的)
2029年4月1日
研究注册日期
首次提交
2026年6月29日
首先提交符合 QC 标准的
2026年6月29日
首次发布 (实际的)
2026年7月6日
研究记录更新
最后更新发布 (实际的)
2026年7月6日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 260528
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Individual participant data that underlie the results reported will be made available after de-identification.
IPD 共享时间框架
The data will become available 3 months following publication of outcomes and will remain available for at least 3 years.
IPD 共享访问标准
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 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.