US NAB With ROSE Versus US FNAB With no ROSE

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618874
• Other study ID #: 3866
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield for a tissue diagnosis		20 days
Secondary	Diagnostic yield for cancer genotyping		30 days
Secondary	Diagnostic yield for PDL1 testing		30 days
Secondary	Complication rate		7 days