Vortex_US: From Benchmark to Surgical Activity: the Role of Endobronchial Fiducial Markers for Ground Glass Lung Nodules Resection.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)

Overall Status

Recruiting

CT.gov ID

NCT05801406

Collaborator

(none)

Enrollment

Location

18.3

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With the risen popularity of low-dose computed tomography (LDCT) for lung cancer screening, many patients present with peripheral pulmonary ground-glass nodules (GGNs) with a suspicious solid part. The appropriate diagnostic and management strategy for those lesions can be questionable. If malignancy is suspected, a surgical biopsy with the guidance of various localization methods available is recommended.

Each localization method has its advantages and disadvantages. Therefore, it may not be possible to establish a gold standard for localizing indeterminate lung nodules since comparative clinical trials are lacking.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Lung Non-Small Cell Carcinoma Lung; Node	Device: Tornado (Cook)

Detailed Description

The management of pulmonary ground-glass nodules (GGNs) may be different. If GGN is an incidental finding through LDCT, the lesion should be followed according to the current guidelines. It is recommend a multidisciplinary team discussion to be initiated if a new solid component develops or the solid portion size grows on follow-up CT as the risk of malignancy is high. Attempts to preoperatively biopsy solid components in part-solid GGNs are often not feasible and not helpful in clinical settings. Currently, if malignancy is suspected, a surgical biopsy with the guidance of various localization methods is recommended. If malignancy is confirmed, sub-lobar resection may provide an excellent oncologic outcome.

The LungVision system is a novel augmented-fluoroscopy-based real-time navigation and guidance technology for bronchoscopy that can enable real-time visualization and localization of pulmonary nodules.

In this study, all patients over the age of 18 will be enrolled in case of finding of lung GGNs with the presence of a solid part inside> = 6 mm or with a solid part even less than 6 mm but with an increase in size. These must be subject to surgical treatment for both diagnostic or therapeutic purposes. These nodules must have a bronchus sign inside. In these patients, a bronchoscopy under general anesthesia with oro-tracheal intubation with LungVision system and r-EBUS will be performed to select the area to mark with fiducial marker. After fiducial marker placement, a CT scan will be performed to control the position of fiducial marker compared to the lesion. Patients will subsequently undergo surgical treatment by using intraoperative ultrasonography to detect the position of fiducial marker in the completely deflated lung. The correct positioning of the fiducial marker compared to the lesion and the complete surgical excision of the target lesion will be evaluated on the surgical specimen.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

From Benchmark to Surgical Activity: the Role of Endobronchial Fiducial Markers for Ground Glass Lung Nodules Resection.

Actual Study Start Date :

Mar 24, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2024

Outcome Measures

Primary Outcome Measures

Rate of adverse events [12 months]
Rate of complications due to endobronchial positioning of fiducial markers under augmented fluoroscopy to mark ground glass opacities.

Secondary Outcome Measures

Number of fiducial markers completely removed [12 months]
Number of fiducial markers placed under augmented fluoroscopy completely removed (margins free from disease) after surgical removal of ground glass opacities in the lung

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

all patients over the age of 18;
lung GGNs with the presence of a solid part inside > = 6 mm or with a solid part even less than 6 mm but with an increase in size;
subjects evaluated for surgical treatment during multidisciplinary tumor board.