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

NCT05801406 | Not Yet Recruiting

• 1 other identifier: IRCSS AOU Bologna
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ultrasound; Marker; Fluoroscopy; Lung; Cancer; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of adverse events

  Rate of complications due to endobronchial positioning of fiducial markers under augmented fluoroscopy to mark ground glass opacities.

  12 months

Secondary Outcomes (1)

• Number of fiducial markers completely removed

  12 months

Interventions

Tornado (Cook) DEVICE

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patients not eligible for surgery

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Gian Piero Bandelli

Bologna, Emilia-Romagna, 40133, Italy

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Gian Piero Bandelli, MD

  AOU Bologna - Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Piero Bandelli, MD

CONTACT

+390512149121; gianpiero.bandelli@hotmail.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 6, 2023
• Study Start: October 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

IT (1)