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

Lung Cancer Clinical Trial

— Vortex_US  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801406
• Other study ID #: IRCSS AOU Bologna
• Status: Recruiting
• Start date: March 24, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2023
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Gian Piero Bandelli, MD
• Phone: +390512149121
• Email: gianpiero.bandelli[@]hotmail.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Patients not eligible for surgery

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Non-Small Cell Carcinoma
• Lung; Node

Intervention

Device:
• Tornado (Cook)
Fiducial marker endobronchial positioning under augmented fluoroscopy to mark ground glass opacities.

Locations

Country	Name	City	State
Italy	Gian Piero Bandelli	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse events	Rate of complications due to endobronchial positioning of fiducial markers under augmented fluoroscopy to mark ground glass opacities.	12 months
Secondary	Number of fiducial markers completely removed	Number of fiducial markers placed under augmented fluoroscopy completely removed (margins free from disease) after surgical removal of ground glass opacities in the lung	12 months