Clinical trial NCT04618874: US NAB With ROSE Versus US FNAB With no ROSE
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Rapid on-site cytological examination
Ultrasound-guided needle aspiration biopsy
Lung adenocarcinoma
Molecular profiling
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield for a tissue diagnosis
timeFrame: 20 days
Secondary outcomes:
measure: Diagnostic yield for cancer genotyping
timeFrame: 30 days
measure: Diagnostic yield for PDL1 testing
timeFrame: 30 days
measure: Complication rate
timeFrame: 7 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Rocco Trisolini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meena N, Bartter T. Ultrasound-guided Percutaneous Needle Aspiration by Pulmonologists: A Study of Factors With Impact on Procedural Yield and Complications. J Bronchology Interv Pulmonol. 2015 Jul;22(3):204-8. doi: 10.1097/LBR.0000000000000175.
citation: Laursen CB, Naur TM, Bodtger U, Colella S, Naqibullah M, Minddal V, Konge L, Davidsen JR, Hansen NC, Graumann O, Clementsen PF. Ultrasound-guided Lung Biopsy in the Hands of Respiratory Physicians: Diagnostic Yield and Complications in 215 Consecutive Patients in 3 Centers. J Bronchology Interv Pulmonol. 2016 Jul;23(3):220-8. doi: 10.1097/LBR.0000000000000297.
citation: Stigt JA, Oostdijk AH, Boers JE, van den Berg JW, Groen HJ. Percutaneous ultrasound-guided biopsies in the evaluation of thoracic tumours after PET-CT: a prospective diagnostic study. Respiration. 2012;83(1):45-52. doi: 10.1159/000330018. Epub 2011 Sep 16.