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

NCT07180823 | Recruiting

• 2 other identifiers: GGN_LungVision_Fiducial_MarkerRC-2024-2790060
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Visualisation (%) of the displacement catheter at the target lesion after 3D reconstruction by the LungVision system software

  Investigate the possibility of reaching the target lung lesion with a fiducial marker displacement catheter, using the Lung Vision System's 'tool in lesion' feature as verification.

  During the bronchoscopy procedure

• Percentage of lung lesions + fiducial markers removed out of the total number of lung lesions undergoing surgery

  Describe the ability to completely resect the ground glass lung lesion marked with a fiducial marker

  During the final post-surgical histological examination (up to 1 month post surgery)

• Number of lung lesions surgically resected with disease-free surgical margins out of the total number of lung lesions resected

  Calculate the percentage of disease-free surgical resection margins out of all procedures performed.

  During the final post-surgical histological examination (up to 1 month post surgery)

• Complication rate (overall and by type: pneumothorax, FM migration, hemoptysis) within one month of surgery.

  Calculate the frequency and type of complications related to fiducial marker placement.

  During the endoscopic procedurePost-operatively (up to 1 month post surgery)At the telephone follow-up one month after surgery

Secondary Outcomes (4)

• Time to navigate to the target nodule (minutes) Time to place the fiducial marker (minutes)

  During the endoscopic procedure

• Distance between: -fiducial marker and target lesion -fiducial marker and resection margins -target lesion and resection margins -target lesion and pleura -fiducial marker and pleura

  During histological examination of the surgical specimen (up to 1 month post surgery)

• Time elapsed in the operating room between the start of the search for the fiducial marker using fluoroscopy and the end of the surgical resection

  During the surgical procedure

• Proportion of lesions in which the fiducial marker is visible with intraoperative ultrasound, calculated as: (n of fiducial markers visible with intraoperative ultrasound) / n total fiducial markers

  During the surgical procedure

Study Arms (1)

Bronchoscopy with Lung Vision navigation system

EXPERIMENTAL

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.

Device: Bronchoscopy with Lung Vision navigation system

Interventions

Bronchoscopy with Lung Vision navigation system 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.

Bronchoscopy with Lung Vision navigation system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Piero Candoli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piero Candoli, MD

CONTACT

+39 051 2145251; piero.candoli@aosp.bo.it

Gian Piero Bandelli, MD

CONTACT

+39 051 2145251; gianpiero.bandelli@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 18, 2025
• Study Start: July 21, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 28, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

IT (1)