Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06533371

Clinical-ultrasonographic Assessment of Pulmonary Emphysema

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-09-26

1628

Participants Needed

4

Research Sites

103 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead Sponsor

M

Miulli General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical-ultrasonographic Assessment of Pulmonary Emphysema

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Outpatients in follow-up for chronic obstructive pulmonary disease, in stable conditions, with computed tomographic evidence of panlobular or paraseptal emphysema.
  • Inpatients admitted to the hospital due to acute exacerbation of chronic obstructive pulmonary disease, with computed tomographic evidence of panlobular or paraseptal emphysema.
  • Subjects participating in the screening program for lung cancer with computed tomographic evidence of panlobular or paraseptal emphysema.
  • Outpatients or inpatients with suspected or known lung cancer and computed tomographic evidence of panlobular or paraseptal emphysema.
  • Patients able to give written informed consent.
Not Eligible

You will not qualify if you...

  • Pregnancy.
  • Pediatric population.
  • Patients unable to express written informed consent.

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Trial Site Locations

Total: 4 locations

1

Ente Ecclesiastico, Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, Italy, 70021

Not Yet Recruiting

2

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

Naples, Italy, 80131

Not Yet Recruiting

3

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

4

University of Trento

Trento, Italy, 38123

Not Yet Recruiting

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Research Team

R

Riccardo Inchingolo, MD, PhD

CONTACT

A

Andrea Smargiassi, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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