The LungVision Navigational Platform for Preoperative Labeling of Pulmonary Ground Glass Nodules With Fiducial Markers

NCT ID: NCT07180823

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2026-02-28

Brief Summary

Based on current evidence, there are no studies investigating the possibility of placing a fiducial marker using augmented fluoroscopy, particularly for partially solid lesions that are often not visible on traditional fluoroscopy. The study in question could provide evidence that will allow, in the future, the use of the LungVision system and radial ultrasound to effectively mark a lesion with a ground glass component highly suspected of malignancy via bronchoscopy, avoiding more invasive marking procedures such as trans-thoracic marking. Correct marking of the target lesion will allow easy identification of the lesion during surgery and its complete removal through small resections, obtaining a definitive histological diagnosis and, in some cases, radical oncological treatment with preservation of healthy lung tissue.

Detailed Description

Lung cancer is the leading cause of cancer-related deaths, accounting for 1.8 million deaths in 2020. For this reason, early screening, diagnosis and treatment play a crucial role in improving the survival rate of lung cancer patients. The cyto-histological typing of peripheral lung nodules can be performed percutaneously (transcutaneous ultrasound or CT-guided biopsy) or bronchoscopically. The CT-guided transcutaneous biopsy approach has a diagnostic yield of over 90%, but carries a high risk of pneumothorax (up to ¼ of cases), which requires chest drainage in up to 5% of cases. The bronchoscopic approach reduces the risk of complications, but the diagnostic yield is significantly lower, ranging from 34% to 63%. The yield of the bronchoscopic approach depends on the size of the lesion (further reduced if less than 20 mm), the presence of an afferent bronchus to the nodule (bronchus sign), the location of the nodule and the experience of the operator. The LungVision system is a navigation system based on augmented fluoroscopy which, using artificial intelligence algorithms, improves the visualisation, localisation and sampling of lung nodules. The system integrates high-resolution computed tomography (HRCT) acquired pre-procedurally with real-time fluoroscopic scans during the procedure to assist the operator in locating and sampling the lesion. Overall, according to the data currently available in the literature, derived mainly from three clinical studies, a high percentage of lesion localisation (between 80 and 94.7%), a diagnostic yield varying between 75 and 87.7% and a high safety profile are reported. Attempts to biopsy the solid component of these nodules in the preoperative phase are often unfeasible or inconclusive in the clinical setting. Currently, if malignancy is highly suspected, surgical biopsy using various localisation methods is recommended. Among the possible localisation methods are the so-called "fiducial markers". These are radiopaque instruments, usually small metal bars or micro-coils, which can be placed inside or near the target lesion to facilitate its localisation during surgical resection or stereotactic radiotherapy. Fiducial markers can be placed percutaneously under CT guidance, endovascularly or, as demonstrated by recent studies, even bronchoscopically using various guidance methods safely and effectively. Bronchoscopic FM placement also offers certain advantages, including the possibility of performing biopsies on lung nodules or lymph nodes during the same session and managing any intra-procedural bleeding. Among the future prospects, one of the possible fields of application of bronchoscopic navigation associated with augmented fluoroscopy could be the placement of fiducial markers for ground glass lesions, which are often not visible with traditional fluoroscopy, given the possibility of verifying the three-dimensional location of the bronchoscope or guide catheter in relation to the target lesion (tool-in-lesion). This would avoid positioning via a more invasive route or one with a higher risk of complications, such as the transthoracic route. For these reasons, it has been hypothesised that the LungVision system, combined with radial endobronchial ultrasound, currently in use in the clinical practice of the Interventional Pulmonology Unit, could be used to locate peripheral lung lesions with a ground-glass component and place a cs-FM via bronchoscopy in the preoperative phase. This would confirm the possibility of placing the FM using the LungVision system combined with radial ultrasound, allowing for subsequent surgical removal and definitive histological typing of the target lesion.

Uncontrolled, monocentric interventional study, to be considered exploratory. Patients who meet the inclusion criteria and have given their informed consent will be enrolled consecutively. No blinding is planned. Patients will undergo bronchoscopy for cytohistological typing of GGN using a needle and/or forceps and/or cryoprobe under radial ultrasound and augmented fluoroscopic guidance, followed by immediate cytological examination in accordance with the normal clinical practice of the operating unit. In the event of cellular atypia or malignant tumour cells, the CT-FM will be placed under augmented fluoroscopic and radial ultrasound guidance to locate and mark the target lung lesion. If the immediate cytological examination is negative, the patient will be excluded from the study. If it is not possible to locate the target lesion using augmented fluoroscopy, the patient will be discharged from the study. On the same day, a chest CT scan will be performed to check the positioning of the FM. The day after the bronchoscopic procedure, the patient will undergo surgery to resect the lung lesion.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Bronchoscopy with Lung Vision navigation system

Augmented fluoroscopy will be used as a guidance tool, which is already in use at our operating unit as part of normal clinical practice, and will be combined with radial ultrasound using a mini probe. Once the peripheral lesion has been located, a cytological and histological sample will be taken using a needle and/or forceps and/or cryoprobe under augmented fluoroscopic guidance and with R-EBUS, as per normal current clinical practice. If atypical cells or malignant tumour cells are found during the extemporaneous cytological examination, the FM, acquired specifically for the study, will be positioned to mark the pulmonary nodule. A coil-tailed FM will be used. Enhanced fluoroscopy will be used via the LungVision system.

Group Type: EXPERIMENTAL

Bronchoscopy with Lung Vision navigation system

Intervention Type: DEVICE

The procedure begins with inspection of the airways up to the subsegmental branches using a flexible bronchoscope. During the procedure, augmented fluoroscopy will be used as a guidance tool, which is already in use at our operating unit as part of normal clinical practice, and will be combined with radial ultrasound using a mini probe. Once the peripheral lesion has been located, a cytological and histological sample will be taken using a needle and/or forceps and/or cryoprobe under augmented fluoroscopic guidance and with R-EBUS, as per normal current clinical practice. If atypical cells or malignant tumour cells are found during the extemporaneous cytological examination, the FM, acquired specifically for the study, will be positioned to mark the pulmonary nodule. A coil-tailed FM will be used. Enhanced fluoroscopy will be used via the LungVision system.

Interventions

Bronchoscopy with Lung Vision navigation system

The procedure begins with inspection of the airways up to the subsegmental branches using a flexible bronchoscope. During the procedure, augmented fluoroscopy will be used as a guidance tool, which is already in use at our operating unit as part of normal clinical practice, and will be combined with radial ultrasound using a mini probe. Once the peripheral lesion has been located, a cytological and histological sample will be taken using a needle and/or forceps and/or cryoprobe under augmented fluoroscopic guidance and with R-EBUS, as per normal current clinical practice. If atypical cells or malignant tumour cells are found during the extemporaneous cytological examination, the FM, acquired specifically for the study, will be positioned to mark the pulmonary nodule. A coil-tailed FM will be used. Enhanced fluoroscopy will be used via the LungVision system.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years;
• Evidence of a partially solid peripheral pulmonary nodule with a solid component ≥ 6 mm or increasing in size, even if smaller, with a bronchus sign or adjacent bronchus on chest CT;
• Obtaining the patient's informed consent.

Exclusion Criteria

• Pregnancy or suspected pregnancy;
• Contraindication to performing bronchoscopy under deep sedation, based on the anesthesiologist's assessment;
• Patient not eligible for surgery due to high surgical risk, based on the anesthesiologist's assessment.

• 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

Piero Candoli

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piero Candoli, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Piero Candoli, MD

Role: CONTACT

piero.candoli@aosp.bo.it

+39 051 2145251

Gian Piero Bandelli, MD

Role: CONTACT

gianpiero.bandelli@aosp.bo.it

+39 051 2145251

Facility Contacts

Piero Candoli, MD

Role: primary

piero.candoli@aosp.bo.it

+39 051 2145251

Gian Piero Bandelli, MD

Role: backup

gianpiero.bandelli@aosp.bo.it

+39 051 2145251

Other Identifiers

RC-2024-2790060

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GGN_LungVision_Fiducial_Marker

Identifier Type: -

Identifier Source: org_study_id