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CompletedNCT04618874Updated Jul 27, 2022

US NAB With ROSE Versus US FNAB With no ROSE

An interventional study of Rapid on-site evaluation in Lung Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Lung Cancer

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Keywords

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

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 136 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    ROSE group

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

    Diagnostic Test: Rapid on-site evaluation

  • No intervention
    US NAB group

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

Interventions

  • Diagnostic testRapid on-site evaluation

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

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What researchers measure

Primary outcomes

  1. Diagnostic yield for a tissue diagnosis

    Time frame: 20 days

Secondary outcomes

  1. Diagnostic yield for cancer genotyping

    Time frame: 30 days

  2. Diagnostic yield for PDL1 testing

    Time frame: 30 days

  3. Complication rate

    Time frame: 7 days

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Study locations

1 site
  • Fondazione Policlinico Universitario A. Gemelli IRCCS
    Roma, Italy
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References and documents

Publications

  • 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. PubMed 26165890 ↗
  • 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. PubMed 27454475 ↗
  • 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. PubMed 21934274 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04618874
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Nov 6, 2020
Start date
Mar 15, 2021
Primary completion
Apr 30, 2022
Completion
May 31, 2022
Last update
Jul 27, 2022

Study contacts

Rocco Trisolini, MD
principal investigator · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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