Clinical trial NCT05801406: From Benchmark to Surgical Activity: the Role of Endobronchial Fiducial Markers for Ground Glass Lung Nodules Resection.
Official title: From Benchmark to Surgical Activity: the Role of Endobronchial Fiducial Markers for Ground Glass Lung Nodules Resection.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Lung Non-Small Cell Carcinoma
Lung; Node
Keywords: Ultrasound
Marker
Fluoroscopy
Lung
Cancer
Bronchoscopy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, all patients over the age of 18 will be selected 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.

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.

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

Primary outcomes:
measure: Rate of adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Number of fiducial markers completely removed
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Gian Piero Bandelli
state: Emilia Romagna
Study officials:
affiliation: AOU Bologna - Italy
name: Gian Piero Bandelli, MD
role: PRINCIPAL_INVESTIGATOR
References: