The LungVision Navigational Platform for Preoperative Labeling of Pulmonary Ground Glass Nodules With Fiducial Markers
Recruiting · NCT07180823 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Based on current evidence, there are no studies investigating the possibility of placing a fiducial marker using augmented fluoroscopy, particularly for partially solid lesions that are often not visible on traditional fluoroscopy. The study in question could provide evidence that will allow, in the future, the use of the LungVision system and radial ultrasound to effectively mark a lesion with a ground glass component highly suspected of malignancy via bronchoscopy, avoiding more invasive marking procedures such as trans-thoracic marking. Correct marking of the target lesion will allow easy identification of the lesion during surgery and its complete removal through small resections, obtaining a definitive histological diagnosis and, in some cases, radical oncological treatment with preservation of healthy lung tissue.
Who can take part
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 it is running
1 location listed.
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Bologna, Bologna, Italy