Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions

Official title

Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions: the SERENE Trial

Overview

This is an investigator-initiated, multicenter, non inferiority, cluster randomized controlled trial. The primary objective is to compare the diagnostic yield of the electromagnetic robotic assisted bronchoscopy with digital tomosynthesis (Galaxy system by Noah Medical) to the shape sensing robotic assisted bronchoscopy with integrated cone beam CT (Ion™ Endoluminal System by Intuitive) in patients undergoing bronchoscopy for peripheral pulmonary lesion (PPL) evaluation.

Detailed description

Millions of nodules are detected every year in the United States. The majority are benign, but some represent early lung cancer and biopsy is often needed to establish the diagnosis. Advanced imaging and navigational guidance systems are routinely used to sample these small peripheral lesions bronchoscopically.

A variety of navigational technologies are currently available, including non-robotic electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB), both cleared by the FDA via the 510(k) pathway. Since market release in 2019, few studies, mostly retrospective and observational studies have reported on the diagnostic yield of RAB which is estimated to be approximately 75-80%. Most of these procedures were performed using conventional fluoroscopy which provides a two-dimensional image to assist with location of the bronchoscope within the chest and with biopsy. However, pulmonary nodules are frequently not visible with conventional fluoroscopy, particularly subsolid or ground glass nodules, which may contribute to non-diagnostic procedures. Thus, the combination of RAB with CBCT, a three-dimensional cross-sectional imaging modality, has been widely adopted by the interventional pulmonology and advanced bronchoscopy community. Cone beam CT produces a near real-time intraprocedural CT image that allows the proceduralist to reposition the robotic bronchoscope based on the location of the bronchoscope relative to that of the nodule and minimize CT to body divergence (CT2BD). Preliminary data suggest that addition of CBCT improves the diagnostic yield. One of the RAB platforms (ssRAB by Intuitive) is now integrated with CBCT, which allows the proceduralist to update the position of the nodule in the navigation system itself. This upgrade is believed to increase the diagnostic yield of ssRAB.

The Galaxy System (Noah Medical) is the latest robotic bronchoscopy platform that integrates its digital tomosynthesis (DT) technology with electromagnetic navigation (EMN) robotic platform with continuous vision. DT is an imaging modality whereby a series of fluoroscopic digital images taken during a partial rotational sweep of a C-arm are superimposed and computationally processed to provide a final three-dimensional image in which the lesion of interest can be far more readily seen than by standard fluoroscopic screening whilst minimizing radiation exposure compared, for example, to CBCT. This new generation Image-Integrated Robotic Assisted Bronchoscopy (ii-RAB) utilizes the advantages of the stability of a robotic bronchoscopy and mitigates CT2BD with imaging confirmation that demonstrates the biopsy tool inside the lesion.

The current assumed pros of using the Galaxy system compared to ssRAB with integrated CBCT is that the procedure may be shorter in time with less use of radiation to the patient and staffs. While the potential downside of the use of DT only without CBCT is that it may be less accurate.

As there are no randomized or retrospective comparative data comparing the two robotic bronchoscopy platforms despite being commercially available and widely utilized, the investigators propose to compare the diagnostic yield of the newest electromagnetic RAB (E-RAB) with integrated digital tomosynthesis (DT) to that of ssRAB with integrated CBCT. Cleveland Clinic and RUSH University currently utilizes both E-RAB with DT and ssRAB with integrated CBCT and they are used interchangeably. Patients are typically assigned arbitrarily to procedures using either platform based on operating room availability.

Thus, the investigator proposes a randomized controlled study to test the hypothesis that the diagnostic yield of E-RAB with DT is not inferior to ssRAB with integrated CBCT in patients undergoing bronchoscopy to biopsy a PPL.

Interventions

• Procedure Bronchoscopy for peripheral pulmonary lesion biopsy
  Participants are scheduled to undergo a bronchoscopy as part of their routine standard of care. Participants will be randomly assigned to one of our two standards of care bronchoscopy robotic platforms (Ion shape sensing robot or Galaxy by Noah electromagnetic robot).

Primary outcome measures

• Diagnostic yield [Time frame: 7 days post enrollment]

Secondary outcome measures (1)

• Radiation Exposure During Study Bronchoscopy [Time frame: During the bronchoscopy procedure]

Eligibility criteria

Inclusion criteria

• ≥ 18 years of age at time of bronchoscopy
• Scheduled for navigational bronchoscopy for the evaluation of pulmonary lesion

Exclusion criteria

1\. Inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Diagnostic

Study locations

United States · 2 centers

• Rush University Medical Center — Chicago
• The Cleveland Clinic — Cleveland

Publications

• Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the A PMID 26367186
• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. PMID 18929686
• 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 De PMID 38394646
• 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
• Saghaie T, Williamson JP, Phillips M, Kafili D, Sundar S, Hogarth DK, Ing A. First-in-human use of a new robotic electromagnetic navigation bronchoscopic platform with integrated Tool-in-Lesion Tomosynthesis (TiLT) technology for peripheral pulmonary lesions: The FRONTIER study. Respirology. 2024 Nov;29(11):969-975. doi: 10.1111/resp.14778. Epub 2024 Jun 24. PMID 38923084
• Bhadra K, Rickman OB, Mahajan AK, Hogarth DK. "Tool-in-lesion" Accuracy of Galaxy System-A Robotic Electromagnetic Navigation BroncHoscopy With Integrated Tool-in-lesion-Tomosynthesis Technology: The MATCH Study. J Bronchology Interv Pulmonol. 2024 Jan 1;31(1):23-29. doi: 10.1097/LBR.0000000000000923. PMID 37072895
• Pritchett MA, Bhadra K, Mattingley JS. Electromagnetic Navigation Bronchoscopy With Tomosynthesis-based Visualization and Positional Correction: Three-dimensional Accuracy as Confirmed by Cone-Beam Computed Tomography. J Bronchology Interv Pulmonol. 2021 Jan 1;28(1):10-20. doi: 10.1097/LBR.0000000000000687. PMID 32412920
• Ferrari A, Bertolaccini L, Solli P, Di Salvia PO, Scaradozzi D. Digital chest tomosynthesis: the 2017 updated review of an emerging application. Ann Transl Med. 2018 Mar;6(5):91. doi: 10.21037/atm.2017.08.18. PMID 29666814

Identifiers

NCT: NCT07411989 · 26-119

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗