Robotic vs Electromagnetic Bronchoscopy for Pulmonary Nodules

(RELIANT 2 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of bronchoscopy, a procedure that allows doctors to see inside the lungs, to determine which is more effective at diagnosing lung nodules, or small growths in the lungs. One method uses a robotic system with advanced imaging, while the other employs electromagnetic navigation bronchoscopy, also with advanced imaging. The trial is for individuals already scheduled for a bronchoscopy to examine a lung nodule. It may be suitable for those advised to undergo this procedure to investigate a spot on the lung. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially enhance diagnostic methods for future patients.

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.

What prior data suggests that these bronchoscopy techniques are safe for diagnosing pulmonary nodules?

Studies have shown that robotic-assisted bronchoscopy is generally easy for patients to tolerate. Research indicates it improves the accuracy of lung nodule biopsies compared to older methods. Most patients undergo the procedure without major issues, though some might experience minor side effects.

Electromagnetic navigation bronchoscopy is also considered safe. Studies have found it to be a reliable method for diagnosing lung problems. Most patients do not encounter significant issues, but, like any medical procedure, some risks exist. Overall, both treatments are effective and safe options for lung biopsy procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two advanced techniques for diagnosing pulmonary nodules: Robotic Assisted Bronchoscopy (RAB) and Electromagnetic Navigation Bronchoscopy (ENB). RAB stands out by integrating a robotic system with cone beam computed tomography, offering precise navigation and enhanced visualization during the procedure. On the other hand, ENB uses digital tomosynthesis to guide the bronchoscope, providing a less invasive option with improved accuracy in locating nodules. These methods could potentially improve both the effectiveness and safety of diagnosing lung conditions compared to the current standard practices, which often rely on conventional bronchoscopy or CT-guided biopsy.

What evidence suggests that this trial's treatments could be effective for diagnosing pulmonary nodules?

This trial will compare Robotic-assisted bronchoscopy (RAB) with Electromagnetic navigation bronchoscopy (ENB) for diagnosing pulmonary nodules. Studies have shown that robotic-assisted bronchoscopy can successfully locate 98% of small lung growths. This method has significantly improved the ability to sample hard-to-reach areas, making it a promising option for diagnosing lung issues. Meanwhile, Electromagnetic navigation bronchoscopy (ENB) has a success rate of about 67.8% in diagnosing these growths, with improved accuracy when combined with other imaging techniques. Although some complications have been reported, ENB allows doctors to take samples and assess the stage of lung issues in one procedure. Both technologies effectively diagnose lung conditions, each with unique strengths in locating lung growths. ^{1 3 4 6 7}

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

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10589535/

Outcomes of the electromagnetic navigation bronchoscopy ... However, procedure-related complications, especially pneumothorax and hemorrhage, have been reported in up to 61% and 5% to 16.9%, respectively.

2. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202301-0099OC

American Journal of Respiratory and Critical Care Medicine The diagnostic yield for ENB is 49%, which increases to 59% with the addition of same-day CT, EBUS, and EMN-TTNA, lower than in prior reports in the literature.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1556086421034146

Electromagnetic Navigation Bronchoscopy for Pulmonary ... ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.

4. lungcancerjournal.info lungcancerjournal.info/article/S0169-5002(23)00734-1/fulltext

Diagnostic yield and safety of navigation bronchoscopy This systematic review analyses the diagnostic yield and safety of navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules ...

5. jto.org jto.org/article/S1556-0864(18)33456-7/fulltext

Electromagnetic Navigation Bronchoscopy for Peripheral ... The NAVIGATE results are the most robust and generalizable ENB data yet collected in the bronchoscopic literature and show that a diagnosis can ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0169500223007341

Diagnostic yield and safety of navigation bronchoscopy This systematic review analyses the diagnostic yield and safety of navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules suspected of lung ...

7. jtd.amegroups.org jtd.amegroups.org/article/view/4423/4819

Meta-analysis of the diagnostic yield and safety of ... Conclusions: ENB is an effective and safe procedure in diagnosing peripheral lung lesions. Keywords: Electromagnetic navigation bronchoscopy (ENB); lung nodules ...