About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients not eligible for surgery
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Tornado (Cook)
DeviceFiducial marker endobronchial positioning under augmented fluoroscopy to mark ground glass opacities.
Treatment groups
Trial outcomes
Primary outcomes
Rate of adverse events
Rate of complications due to endobronchial positioning of fiducial markers under augmented fluoroscopy to mark ground glass opacities.
Secondary outcomes
Number of fiducial markers completely removed
Number of fiducial markers placed under augmented fluoroscopy completely removed (margins free from disease) after surgical removal of ground glass opacities in the lung
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: