US NAB With ROSE Versus US FNAB With no ROSE

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

Lung Cancer

Treatments

Diagnostic Test: Rapid on-site evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT04618874

3866

Details and patient eligibility

About

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.

Enrollment

136 patients

Sex

All

Ages

18+ years old

Volunteers

No 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