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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tornado (Cook)

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

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

Time frame
12 months

Other outcomes

Sponsors and contacts

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