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The LungVision Navigational Platform for Preoperative Labeling of Pulmonary Ground Glass Nodules With Fiducial Markers
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2025-07-21
Completion Date
2026-02-28
Last Updated
2025-09-18
Healthy Volunteers
No
Conditions
Interventions
Bronchoscopy with Lung Vision navigation system
The procedure begins with inspection of the airways up to the subsegmental branches using a flexible bronchoscope. During the procedure, augmented fluoroscopy will be used as a guidance tool, which is already in use at our operating unit as part of normal clinical practice, and will be combined with radial ultrasound using a mini probe. Once the peripheral lesion has been located, a cytological and histological sample will be taken using a needle and/or forceps and/or cryoprobe under augmented fluoroscopic guidance and with R-EBUS, as per normal current clinical practice. If atypical cells or malignant tumour cells are found during the extemporaneous cytological examination, the FM, acquired specifically for the study, will be positioned to mark the pulmonary nodule. A coil-tailed FM will be used. Enhanced fluoroscopy will be used via the LungVision system.
Locations (1)
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy