Robotic-assisted Bronchoscopy for Lung Nodules

(SEQUENCE Trial)

Overseen By Chris Kapp Assistant professor of medicine, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Enlarged lymph nodes, PET avid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for biopsying lung nodules using robotic-assisted bronchoscopy (RaB). The goal is to determine whether performing the RaB procedure before or after a specific ultrasound test (called EBUS) affects diagnostic accuracy and safety. The trial compares these two approaches to identify the optimal order for these procedures. It targets individuals with a lung nodule requiring a biopsy, who do not have enlarged lymph nodes visible on a CT scan. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance diagnostic procedures for lung nodules.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that robotic-assisted bronchoscopy is safe for lung nodule procedures?

Research has shown that robotic-assisted bronchoscopy (RaB) is generally safe. In a recent study, only 3.8% of participants experienced issues such as a collapsed lung or bleeding, and no one experienced breathing failure. This indicates that RaB is well-tolerated. Additionally, RaB improves the accuracy of lung nodule biopsies compared to older methods. Overall, these findings suggest that RaB is a promising and relatively safe option for those considering participation in related trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic-assisted bronchoscopy for lung nodules because it offers a cutting-edge way to access hard-to-reach areas of the lung. Unlike traditional bronchoscopy, which relies on manual tools and can be limited by the physician’s reach, this method uses robotic precision to navigate complex lung anatomy. This precision can potentially improve biopsy accuracy, leading to better diagnosis and treatment outcomes. Additionally, combining it with endobronchial ultrasound (EBUS) provides a comprehensive approach to evaluating mediastinal lymph nodes, which could streamline the diagnostic process and reduce the need for multiple invasive procedures.

What evidence suggests that robotic-assisted bronchoscopy is effective for lung nodules?

Research has shown that robotic-assisted bronchoscopy can effectively reach and sample difficult-to-access lung nodules. Studies report a success rate of 70-85% in diagnosing issues, surpassing older techniques. This method accurately identifies problems in many cases. In this trial, one group of participants will first undergo robotic-assisted bronchoscopy, followed by a mediastinal lymph node evaluation with EBUS. Another group will have the EBUS evaluation first, followed by robotic-assisted bronchoscopy. Additionally, using robotic-assisted bronchoscopy with cone-beam CT (a type of imaging technology) helps doctors ensure correct needle placement during the procedure. Although large-scale comparisons with other methods are not yet available, these findings suggest that robotic-assisted bronchoscopy is a promising tool for diagnosing lung nodules. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with small lung nodules needing a biopsy using robotic-assisted bronchoscopy. It's not open to those who already have enlarged or PET avid lymph nodes visible on CT scans before the procedure.

Inclusion Criteria

I am having a robotic-assisted bronchoscopy for a lung nodule.

Exclusion Criteria

My lymph nodes are enlarged or showed up on a PET scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo either a linear EBUS first followed by robotic-assisted bronchoscopy or vice versa, to evaluate diagnostic yield and safety outcomes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for diagnostic yield and atelectasis impact, assessed 30 days after the procedure

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Robotic-assisted Bronchoscopy

Trial Overview The study tests whether doing a staging EBUS (a type of ultrasound) before or after the robotic biopsy affects accuracy, occurrence of atelectasis (lung collapse), and safety in diagnosing lung nodules.

How Is the Trial Designed?

Group I: Linear EBUS First Active Control 1 Intervention

Patients will undergo a mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy

Group II: Robotic-assisted bronchoscopy first Active Control 1 Intervention

Patients will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second

Robotic-assisted Bronchoscopy is already approved in United States, European Union for the following indications:

Approved in United States as Robotic-assisted Bronchoscopy for:

• Diagnosis and staging of lung cancer
• Biopsy of pulmonary nodules

Approved in European Union as Robotic-assisted Bronchoscopy for:

• Diagnosis and staging of lung cancer
• Biopsy of pulmonary nodules

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Robotic-assisted navigation bronchoscopy (RANB) has a high diagnostic yield of 81.9% for lung nodules, indicating it is an effective method for obtaining biopsies, based on a meta-analysis of 23 studies involving 1409 patients.

The complication rates associated with RANB are low, with pneumothorax occurring in only 0.60% of cases and major bleeding rates being less than 0.01%, suggesting that RANB is a safe option for lung nodule biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted Navigation Bronchoscopy: A Meta-Analysis of Diagnostic Yield and Complications. Pyarali, FF., Hakami-Majd, N., Sabbahi, W., et al.[2023]

Robotic-assisted bronchoscopy offers a promising advancement for obtaining biopsies of peripheral pulmonary lesions, addressing the limitations of traditional bronchoscopic methods that often yield suboptimal results.

The review highlights the feasibility and sensitivity of various robotic-assisted platforms, suggesting they may improve diagnostic accuracy in lung biopsies compared to conventional techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Robotic-Assisted Bronchoscopy Platforms in the Sampling of Peripheral Pulmonary Lesions. Lu, M., Nath, S., Semaan, RW.[2021]

Robotic-assisted bronchoscopy marks a significant advancement in bronchoscopic techniques, but there is a lack of documented strategies for managing severe airway bleeding in this context.

The case report outlines a novel approach using a combination of flexible and robotic bronchoscopy to effectively address complications related to airway bleeding, highlighting the need for further guidance in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Significant Airway Bleeding during Robotic Assisted Bronchoscopy: A Tailored Approach. Fernandez-Bussy, S., Abia-Trujillo, D., Majid, A., et al.[2021]

Robotic bronchoscopy improves the ability to navigate and biopsy peripheral pulmonary lesions compared to traditional methods, addressing issues like limited maneuverability and target confirmation.

While robotic bronchoscopy enhances tissue acquisition and reach in the airways, it currently lacks a high-fidelity system for confirming the biopsy target, indicating that further studies are needed to evaluate its effectiveness in diagnosing lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic bronchoscopy for peripheral pulmonary lesions: a convergence of technologies. Lin, J., Ost, DE.[2021]

Robotic bronchoscopy (RB) demonstrated a diagnostic accuracy of 77% for lung lesions, with higher accuracy (85%) for lesions with concentric radial endobronchial ultrasound (r-EBUS) views, indicating its effectiveness in improving diagnostic outcomes.

The procedure had a low complication rate, with only 1.6% of patients experiencing pneumothorax and 3.2% reporting bleeding, while no cases of post-procedure respiratory failure were noted, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Diagnostic Accuracy of Robotic Bronchoscopy With 12-Month Follow-up. Agrawal, A., Ho, E., Chaddha, U., et al.[2023]

In a study of 25 patients, robotic-assisted bronchoscopy achieved a high diagnostic yield of 96% for lung nodules, with no reported complications during the procedure.

The majority of the nodules evaluated were found to be malignant or atypical (76%), indicating that this method is not only safe but also effective in diagnosing potentially serious conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Nodule Evaluation Using Robotic-Assisted Bronchoscopy at a Veteran's Affairs Hospital. Ekeke, CN., Vercauteren, M., Istvaniczdravkovic, S., et al.[2021]

Citations

1. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/precision-and-progress-robotic-assisted-bronchoscopy-reshapes-early-lung-cancer-management

Robotic-Assisted Bronchoscopy Reshapes Early Lung Cancer ... Navigational bronchoscopy technologies have transformed clinicians' ability to biopsy hard-to-reach peripheral lung nodules.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11968345/

Robotic-assisted lung nodule diagnosis and resection - PMC Data are continually emerging that robotic assisted procedures may offer improved lung cancer diagnostic capability and surgical outcomes ...

3. journal.chestnet.org journal.chestnet.org/article/S0012-3692(25)00548-3/fulltext

A Prospective, Multicenter Evaluation of Safety and Diagnostic ... Robotic-assisted bronchoscopy (RAB) is gaining adoption for navigation to PPLs. However, evidence from large studies remains limited.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022522325004647

Diagnostic effectiveness and safety of robotic-assisted ... To analyze the effectiveness and safety of robotic-assisted bronchoscopy (RAB) for subsolid nodules, including semisolid nodules (SSNs) and ground-glass nodules ...

5. intuitive.com intuitive.com/en-us/products-and-services/ion/research-outcomes

Latest Research on Ion Robotic Bronchoscopy Examining outcomes data helps generate evidence showing the potential role of Ion endoluminal systems in the patient journey for lung nodule biopsy. Several ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10170714/

Diagnostic outcomes of robotic-assisted bronchoscopy for ... RAB demonstrated a high diagnostic yield in the largest study to date, despite representing a real-world community population with a relatively low prevalence ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0012369225005483

A Prospective, Multicenter Evaluation of Safety and ... Results: The adjudicated primary safety end point was observed in 3.8% of participants (19 pneumothorax, 7 bleeding, and 0 respiratory failure).

8. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.202301-075OC

Diagnostic Performance and Safety Profile of Robotic ... Conclusions: RAB systems have significantly increased the diagnostic yield of navigational bronchoscopy compared with conventional systems such ...