search
Back to results

US NAB With ROSE Versus US FNAB With no ROSE

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rapid on-site evaluation
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung cancer, Rapid on-site cytological examination, Ultrasound-guided needle aspiration biopsy, Lung adenocarcinoma, Molecular profiling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ROSE group

US NAB group

Arm Description

Ultrasound-assisted percutaneous needle aspiration with rapid on-site evaluation

Ultrasound-assisted percutaneous needle aspiration without rapid on-site evaluation

Outcomes

Primary Outcome Measures

Diagnostic yield for a tissue diagnosis

Secondary Outcome Measures

Diagnostic yield for cancer genotyping
Diagnostic yield for PDL1 testing
Complication rate

Full Information

First Posted
November 2, 2020
Last Updated
July 26, 2022
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
search

1. Study Identification

Unique Protocol Identification Number
NCT04618874
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, Rapid on-site cytological examination, Ultrasound-guided needle aspiration biopsy, Lung adenocarcinoma, Molecular profiling

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ROSE group
Arm Type
Experimental
Arm Description
Ultrasound-assisted percutaneous needle aspiration with rapid on-site evaluation
Arm Title
US NAB group
Arm Type
No Intervention
Arm Description
Ultrasound-assisted percutaneous needle aspiration without rapid on-site evaluation
Intervention Type
Diagnostic Test
Intervention Name(s)
Rapid on-site evaluation
Intervention Description
Rapid on site evaluation performed with an MGG quick stain (Bio-Optica, Milano, Italy).
Primary Outcome Measure Information:
Title
Diagnostic yield for a tissue diagnosis
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Diagnostic yield for cancer genotyping
Time Frame
30 days
Title
Diagnostic yield for PDL1 testing
Time Frame
30 days
Title
Complication rate
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocco Trisolini, MD
Organizational Affiliation
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26165890
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.
Results Reference
background
PubMed Identifier
27454475
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.
Results Reference
background
PubMed Identifier
21934274
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.
Results Reference
background

Learn more about this trial

US NAB With ROSE Versus US FNAB With no ROSE

We'll reach out to this number within 24 hrs