US NAB With ROSE Versus US FNAB With no ROSE

A RANDOMIZED TRIAL COMPARING PERCUTANEOUS ULTRASOUND-GUIDED NEEDLE ASPIRATION/BIOPSY WITH AND WITHOUT RAPID ON SITE EVALUATION IN PATIENTS WITH SUSPECTED SUPERFICIAL METASTASIS FROM LUNG CANCER

This is an investigator-initiated, single center, controlled, randomized clinical trial with two parallel arms in a 1:1 ratio. The objective of the study is to systematically assess the influence of rapid on-site evaluation (ROSE) on the diagnostic yield for diagnosis and molecular profiling, as well as on the safety, of pulmonologist-performed ultrasound-assisted needle aspiration biopsy (US-NAB) of superficial lesions across different metastatic sites in a series of consecutive patients with suspect locally advanced or advanced lung cancer.

Inclusion Criteria:

• Known/suspected lung cancer
• Presence of a suspected "superficial" metastasis at imaging studies (CT and/or PET)
• Indication to tissue sampling for diagnosis, staging and/or molecular profiling
• 18 years or older
• Provision of a written informed consent

Exclusion Criteria:

• Inability or unwillingness to consent
• Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
• Use of antiplatelet (excluded aspirin) or anticoagulant drugs that cannot be discontinued