US NAB With ROSE Versus US FNAB With no ROSE

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Rapid on-site evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROSE group<br>Ultrasound-assisted percutaneous needle aspiration with rapid on-site evaluation | Diagnostic Test: Rapid on-site evaluation<br>* Rapid on site evaluation performed with an MGG quick stain (Bio-Optica, Milano, Italy).<br>|
| No Intervention: US NAB group<br>Ultrasound-assisted percutaneous needle aspiration without rapid on-site evaluation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield for a tissue diagnosis |  | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield for cancer genotyping |  | 30 days | 
| Diagnostic yield for PDL1 testing |  | 30 days | 
| Complication rate |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Rapid on-site cytological examination, Ultrasound-guided needle aspiration biopsy, Lung adenocarcinoma, Molecular profiling