Using LungVision navigation to place markers on ground-glass lung nodules before surgery

The LungVision Navigational Platform for Preoperative Labeling of Pulmonary Ground Glass Nodules With Fiducial Markers

This trial tests whether the LungVision augmented fluoroscopy system can place small fiducial markers during bronchoscopy to label partially solid ground-glass lung nodules in adults who are surgical candidates.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (other)
• Locations: 1 site (Bologna, Bologna)
• Trial ID: NCT07180823 on ClinicalTrials.gov

What this trial studies

This interventional study uses the LungVision augmented fluoroscopy navigation system combined with pre-procedure high-resolution CT and radial endobronchial ultrasound to guide bronchoscopy and place small fiducial markers into partially solid ground-glass pulmonary nodules. Markers are placed bronchoscopically under deep sedation so surgeons can more easily locate the lesion during subsequent minimally invasive surgery. The approach aims to reduce complications associated with percutaneous transthoracic marking, such as pneumothorax, and to enable smaller, tissue-sparing resections. Enrollment is at a single academic center in Bologna, Italy, with eligibility based on lesion size and presence of a bronchus sign on CT.

Who should consider this trial

Good fit: Adults (≥18 years) with a partially solid peripheral pulmonary nodule having a solid component ≥6 mm or with documented growth, a bronchus sign or adjacent bronchus on chest CT, who can undergo bronchoscopy under deep sedation and are eligible for surgery.

Not a fit: Patients who cannot tolerate bronchoscopy or deep sedation, who are not surgical candidates, or who are pregnant will likely not benefit from this procedure.

Why it matters

Potential benefit: If successful, this method could make it easier to locate and remove suspicious ground-glass nodules with smaller, lung-sparing surgeries while avoiding higher-risk transthoracic marking procedures.

How similar studies have performed: Early reports from a small number of studies using LungVision or similar augmented fluoroscopic navigation combined with radial EBUS have shown promising localization rates, but the overall evidence is still limited.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years;
* Evidence of a partially solid peripheral pulmonary nodule with a solid component ≥ 6 mm or increasing in size, even if smaller, with a bronchus sign or adjacent bronchus on chest CT;
* Obtaining the patient's informed consent.

Exclusion Criteria:

* Pregnancy or suspected pregnancy;
* Contraindication to performing bronchoscopy under deep sedation, based on the anesthesiologist's assessment;
* Patient not eligible for surgery due to high surgical risk, based on the anesthesiologist's assessment.

Where this trial is running

Bologna, Bologna

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)

Study contacts

• Principal investigator: Piero Candoli, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Piero Candoli, MD

Conditions: Lung Cancer