Robotic vs Electromagnetic Bronchoscopy for Pulmonary Nodules

(RELIANT 2 Trial)

Recruiting at 2 trial locations

Overseen By Fabien Maldonado, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Participation refusal, Other trial enrollment

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.

Do I need to stop my current medications for this trial?

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.

Is electromagnetic navigation bronchoscopy (ENB) safe for humans?

Research indicates that electromagnetic navigation bronchoscopy (ENB) is generally safe for humans, including those with chronic obstructive pulmonary disease (COPD) and poor lung function. Studies have evaluated its safety in various contexts, such as aiding in the localization of lung lesions for biopsy and surgical procedures. ^{1 2 3 4 5}

How is robotic-assisted bronchoscopy different from other treatments for pulmonary nodules?

Robotic-assisted bronchoscopy is a newer technology that offers improved visualization and localization of lung nodules compared to traditional electromagnetic navigational bronchoscopy, potentially increasing diagnostic accuracy. It is designed to overcome limitations of existing methods, such as CT-guided biopsies, by providing real-time navigation and a higher diagnostic yield with fewer complications. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Robotic vs Electromagnetic Bronchoscopy for Pulmonary Nodules?

Electromagnetic navigation bronchoscopy (ENB) is shown to help accurately locate lung lesions for biopsy and surgical procedures, and it may be safer and more effective than some other methods like computed tomography-guided localization. Additionally, advanced ENB systems have been developed to improve accuracy by correcting for differences between pre-procedure scans and actual anatomy during the procedure. ^{1 2 3 4 9}

Who Is on the Research Team?

Rafael Paez, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who need a biopsy of lung nodules or lesions. Participants should be suitable candidates for bronchoscopy, a procedure to look inside the lungs' airways.

Inclusion Criteria

I am scheduled for a special lung scan to check a spot.

Exclusion Criteria

I choose not to participate in the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either robotic assisted bronchoscopy with integrated cone beam computed tomography or electromagnetic navigation bronchoscopy with integrated digital tomosynthesis for biopsy of a pulmonary lesion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for diagnostic yield and safety post-procedure

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Electromagnetic navigation bronchoscopy
• Robotic assisted bronchoscopy

Trial Overview The RELIANT 2 study is comparing two advanced bronchoscopy techniques: Robotic Assisted Bronchoscopy (RAB) with CT imaging and Electromagnetic Navigation Bronchoscopy (ENB) with digital imaging, to see which one better identifies lung issues.

How Is the Trial Designed?

Group I: Robotic assisted bronchoscopy (RAB) Active Control 1 Intervention

Robotic assisted bronchoscopy with integrated cone beam computed tomography

Group II: Electromagnetic navigation bronchoscopy (ENB) Active Control 1 Intervention

Electromagnetic navigation bronchoscopy (ENB) with integrated digital tomosynthesis

Electromagnetic navigation bronchoscopy is already approved in United States, European Union for the following indications:

Approved in United States as Electromagnetic navigation bronchoscopy for:

• Peripheral pulmonary nodules that require a pathologic diagnosis and are not accessible by standard bronchoscopy methods or by a transthoracic biopsy approach
• Placement of fiducial markers in patients who are not candidates for surgical intervention and who have elected to undergo radiation therapy

Approved in European Union as Electromagnetic navigation bronchoscopy for:

• Diagnosis of peripheral lung lesions
• Diagnosis of mediastinal lymph nodes

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

The multimodality navigation bronchoscopy (MNB) platform achieved a high diagnostic yield of 79% for sampling pulmonary lesions, with an even higher yield of 83% when using digital tomosynthesis.

The safety profile of the MNB system was favorable, with low complication rates of 3% for pneumothorax and 2% for bleeding requiring intervention, and no hospital admissions related to the procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sight Unseen: Diagnostic Yield and Safety Outcomes of a Novel Multimodality Navigation Bronchoscopy Platform with Real-Time Target Acquisition. Avasarala, SK., Roller, L., Katsis, J., et al.[2022]

In a study of 117 patients undergoing minimally invasive resection for pulmonary nodules, both electromagnetic navigational bronchoscopy (ENB) and computed tomography (CT) localization were equally effective at localizing the nodules, with a 100% success rate for both methods.

ENB not only matched the safety and effectiveness of CT-guided localization but also significantly reduced the waiting time between localization and surgery (27 minutes for ENB vs. 189 minutes for CT), making it a more efficient option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic Navigational Bronchoscopy Reduces the Time Required for Localization and Resection of Lung Nodules. Bolton, WD., Cochran, T., Ben-Or, S., et al.[2022]

Electromagnetic navigation bronchoscopy (ENB) demonstrated a 61.1% positive diagnosis rate for peripheral lung lesions, with a sensitivity of 73.3%, indicating its effectiveness in diagnosing conditions like lung cancer and tuberculosis.

The diagnostic accuracy of ENB significantly improves for lesions larger than 2 cm, achieving a 100% positive diagnosis rate for these cases, suggesting its potential for broader clinical application in lung diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical Application of Electromagnetic Navigation Bronchoscopy on the Diagnosis of Peripheral Lung Lesions]. Xue, M., Wang, J., Han, Y., et al.[2021]

In a study of 1000 patients undergoing electromagnetic navigation bronchoscopy (ENB), the complication rates were similar for patients with chronic obstructive pulmonary disease (COPD) and those without, indicating that ENB is safe for patients with compromised lung function.

The risk of pneumothorax, a common concern during lung procedures, was not significantly higher in patients with COPD, suggesting that ENB could be a preferred method for biopsying lung lesions in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Electromagnetic Navigation Bronchoscopy in Patients With COPD: Results From the NAVIGATE Study. Towe, CW., Nead, MA., Rickman, OB., et al.[2019]

A study involving 50 subjects with peripheral lung lesions showed that the advanced electromagnetic navigation bronchoscopy (ENB) system significantly improved localization accuracy, achieving 83% target overlap after location correction, compared to 60% before correction.

The procedure had a low complication rate, with only one case of pneumothorax and three cases of minor hemoptysis, indicating that the ENB system is safe for use in lung lesion biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic Navigation Bronchoscopy With Tomosynthesis-based Visualization and Positional Correction: Three-dimensional Accuracy as Confirmed by Cone-Beam Computed Tomography. Pritchett, MA., Bhadra, K., Mattingley, JS.[2023]

In a study of 56 patients with small peripheral pulmonary nodules, electromagnetic navigation bronchoscopy (ENB) combined with radial endobronchial ultrasound (R-EBUS) demonstrated a significantly better negative predictive value compared to ENB combined with x-ray, indicating improved diagnostic accuracy for smaller nodules.

The findings suggest that using R-EBUS alongside ENB can enhance the ability to accurately diagnose small nodules that conventional bronchoscopy cannot reach, potentially leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of the efficacy and safety of electromagnetic navigation bronchoscopy combined with x-ray or radial endobronchial ultrasound biopsy in the diagnosis of small peripheral pulmonary nodules. Fu, Y., Yuan, X., Pan, W., et al.[2023]

Robotic bronchoscopy shows promise as a new technology that could improve the diagnosis of small lung lesions compared to traditional methods like electromagnetic navigational bronchoscopy and CT-guided biopsies.

The use of real-time tools such as electromagnetic navigation and radial-endobronchial ultrasound in robotic bronchoscopy may enhance the accuracy and effectiveness of diagnosing and staging lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotics in the diagnosis and staging of lung cancer. Freyaldenhoven, ST., Tsukada, H.[2023]

The RELIANT trial is a groundbreaking study comparing robotic assisted bronchoscopy to electromagnetic navigational bronchoscopy for diagnosing peripheral pulmonary lesions, involving approximately 400 patients and aiming to assess the diagnostic yield of each method.

This trial is significant as it is the first randomized controlled trial of robotic assisted bronchoscopy, which may offer advantages like an easier learning curve, and it will provide valuable insights into the safety and efficacy of these two bronchoscopic techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial. Paez, R., Lentz, RJ., Salmon, C., 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. Switzerland pubmed.ncbi.nlm.nih.gov

Sight Unseen: Diagnostic Yield and Safety Outcomes of a Novel Multimodality Navigation Bronchoscopy Platform with Real-Time Target Acquisition. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Electromagnetic Navigational Bronchoscopy Reduces the Time Required for Localization and Resection of Lung Nodules. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Clinical Application of Electromagnetic Navigation Bronchoscopy on the Diagnosis of Peripheral Lung Lesions]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Safety of Electromagnetic Navigation Bronchoscopy in Patients With COPD: Results From the NAVIGATE Study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Electromagnetic Navigation Bronchoscopy With Tomosynthesis-based Visualization and Positional Correction: Three-dimensional Accuracy as Confirmed by Cone-Beam Computed Tomography. [2023]

6. Singapore pubmed.ncbi.nlm.nih.gov

Comparative analysis of the efficacy and safety of electromagnetic navigation bronchoscopy combined with x-ray or radial endobronchial ultrasound biopsy in the diagnosis of small peripheral pulmonary nodules. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Robotics in the diagnosis and staging of lung cancer. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Lung Nodule Evaluation Using Robotic-Assisted Bronchoscopy at a Veteran's Affairs Hospital. [2021]