To hear about similar clinical trials, please enter your email below

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

NCT ID: NCT05801406

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

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Ultrasound
Marker
Fluoroscopy
Lung
Cancer
Bronchoscopy

Study type: Observational [Patient Registry]

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Tornado (Cook)
Description: Fiducial marker endobronchial positioning under augmented fluoroscopy to mark ground glass opacities.

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Gian Piero Bandelli

Address:
City: Bologna
Zip: 40133
Country: Italy

Contact:
Last name: Gian Piero Bandelli, MD

Phone: +390512149121
Email: gianpiero.bandelli@aosp.bo.it

Contact backup:
Last name: Niccolò Daddi, MD, PhD

Phone: +390512149049
Email: niccolo.daddi@unibo.it

Start date: October 1, 2024

Completion date: October 31, 2025

Lead sponsor:
Agency: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Agency class: Other

Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05801406

Login to your account

Did you forget your password?