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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04618874

Enrollment

136

Registered

2020-11-06

Start date

2021-03-15

Completion date

2022-05-31

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung cancer, Rapid on-site cytological examination, Ultrasound-guided needle aspiration biopsy, Lung adenocarcinoma, Molecular profiling

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.

Interventions

DIAGNOSTIC_TESTRapid on-site evaluation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Diagnostic yield for a tissue diagnosis	20 days

Secondary

Measure	Time frame
Diagnostic yield for cancer genotyping	30 days
Diagnostic yield for PDL1 testing	30 days
Complication rate	7 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026