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RECRUITING
NCT06533371
NA

Clinical-ultrasonographic Assessment of Pulmonary Emphysema

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to identify correlations among data deriving from lung ultrasonographic (LUS) and tomographic evaluations of patients with panlobular or paraseptal emphysema, to improve the comprehension of acoustic information derived from ultrasound evaluation. The main question it aims to answer is: what are the correlations between thoracic ultrasonographic patterns and peripheral parenchymal changes evaluated by high resolution computed tomography (HRCT) of the chest, in patients affected with variable degree of panlobular or paraseptal emphysema? Researchers will compare LUS patterns observed in: 1) COPD patients with CT evidence of panlobular or paraseptal emphysema, 2) subjects participating in the screening program for lung cancer with CT evidence of panlobular or paraseptal emphysema, and 3) patients with suspected/known lung cancer undergoing with CT evidence of panlobular or paraseptal emphysema, with the ones obtained from healthy volunteers and subjects who participate in the screening program for lung cancer with no evidence of emphysema. Participants will undergo LUS evaluation with both clinical and research scanners. Patients will be assessed in supine position with the arms extended above the head. The position is the same in which chest CT scans will be performed. LUS assessment will be performed using commercially available linear probes. Finally, all COPD patients and subjects who participate in the screening program for lung cancer with CT evidence of paraseptal or panlobular emphysema will undergo respiratory oscillometry. Tidal breathing analysis with impulse oscillometry (IOS) has proven to be an informative and meaningful tool used in the early detection and follow up of pulmonary diseases like COPD.

Official title: Assessment of Pulmonary EmphySema: the Clinical -ULtrasonographic APproach to chronIc Obstructive Pulmonary Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1628

Start Date

2024-09-04

Completion Date

2026-08-31

Last Updated

2024-09-26

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Relationship between lung ultrasound and computed tomographic scan

Ultrasonographic findings will be obtained with clinical machines. Additionally, US scans as acquired with the Ula-Op open research platform will also be gathered. For both scanners, 10seconds videos will be recorded and stored in each landmark. To correlate LUS artefactual patterns with peripheral parenchymal changes evaluated by HRCT of the chest, all chest CT findings will be analysed by an image processing platform designed to provide visualization and quantification of areas with abnormal CT tissue density indicative of emphysema and air trapping. Post-processing image analysis will be performed on images by using automated detection of potential emphysema systems.

Locations (4)

Ente Ecclesiastico, Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, Italy

A.O.R.N. "A. Cardarelli"

Naples, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy

University of Trento

Trento, Italy