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

NCT ID: NCT05801406

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-10-31

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Tornado (Cook)

Fiducial marker endobronchial positioning under augmented fluoroscopy to mark ground glass opacities.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

bandelli

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gian Piero Bandelli, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Bologna - Italy

Locations

Gian Piero Bandelli

Bologna, Emilia-Romagna, Italy

Countries

Italy

Central Contacts

Gian Piero Bandelli, MD

Role: CONTACT

gianpiero.bandelli@hotmail.it

+390512149121

Facility Contacts

Gian Piero Bandelli, MD

Role: primary

gianpiero.bandelli@aosp.bo.it

+390512149121

Niccolò Daddi, MD, PhD

Role: backup

niccolo.daddi@unibo.it

+390512149049

Other Identifiers

IRCSS AOU Bologna

Identifier Type: -

Identifier Source: org_study_id