US NAB With ROSE Versus US FNAB With no ROSE

Fondazione Policlinico Universitario Agostino Gemelli IRCCS136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

136

Conditions

Lung Cancer

Interventions

Rapid on-site evaluationDIAGNOSTIC_TEST

Rapid on site evaluation performed with an MGG quick stain (Bio-Optica, Milano, Italy).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Outcomes

Primary Outcomes

Diagnostic yield for a tissue diagnosis

Time frame: 20 days

Secondary Outcomes

Diagnostic yield for cancer genotyping

Time frame: 30 days

Diagnostic yield for PDL1 testing

Time frame: 30 days

Complication rate

Time frame: 7 days

Data from ClinicalTrials.gov

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