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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Visualisation (%) of the displacement catheter at the target lesion after 3D reconstruction by the LungVision system software — During the bronchoscopy procedure
  Investigate the possibility of reaching the target lung lesion with a fiducial marker displacement catheter, using the Lung Vision System's 'tool in lesion' feature as verification.
• Percentage of lung lesions + fiducial markers removed out of the total number of lung lesions undergoing surgery — During the final post-surgical histological examination (up to 1 month post surgery)
  Describe the ability to completely resect the ground glass lung lesion marked with a fiducial marker
• Number of lung lesions surgically resected with disease-free surgical margins out of the total number of lung lesions resected — During the final post-surgical histological examination (up to 1 month post surgery)
  Calculate the percentage of disease-free surgical resection margins out of all procedures performed.
• Complication rate (overall and by type: pneumothorax, FM migration, hemoptysis) within one month of surgery. — During the endoscopic procedurePost-operatively (up to 1 month post surgery)At the telephone follow-up one month after surgery
  Calculate the frequency and type of complications related to fiducial marker placement.

Trial sites (1)

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