US NAB With ROSE Versus US FNAB With no ROSE
Not Applicable
Completed
- Conditions
- Lung Cancer
- Interventions
- Diagnostic Test: Rapid on-site evaluation
- Registration Number
- NCT04618874
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ROSE group Rapid on-site evaluation Ultrasound-assisted percutaneous needle aspiration with rapid on-site evaluation
- Primary Outcome Measures
Name Time Method Diagnostic yield for a tissue diagnosis 20 days
- Secondary Outcome Measures
Name Time Method Diagnostic yield for PDL1 testing 30 days Complication rate 7 days Diagnostic yield for cancer genotyping 30 days
Trial Locations
- Locations (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS
🇮🇹Roma, Italy