Clinical-ultrasonographic Assessment of Pulmonary Emphysema (ESCULAPIO)

May 19, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The use of lung ultrasound (LUS) is instrumental in the evaluation of many thoracic diseases and its ability to detect pleural-pulmonary pathologies is widely accepted. However, the use of LUS as an indication of underlying parenchymal lung disease, when the organ is still aerated, is a relatively new application. A-lines and B-lines are two separate and distinct artifacts which may be seen during the examination of the nonconsolidated lungs by ultrasound because of different underlying structures. Even though the practical role of LUS artifacts is accepted for detecting and monitoring many conditions, we do not fully understand their origin. The artifactual information beyond the pleura line in LUS images of the normal and of the not critically deflated lung represents the ultimate outcome of complex interactions of a specific acoustic wave with a specific three-dimensional structure of the biological tissue.

Chronic obstructive pulmonary disease (COPD) is a complex condition with a wide spectrum of clinical presentations and pathological features unified under the spirometric definition of airflow obstruction. The mechanisms responsible for airflow obstruction in COPD (airway narrowing and parenchymal destruction) cannot be distinguished by standard spirometry.

Chest computed tomography (CT) allows to depict and measure in vivo the lung pathologic changes of COPD by quantifying parenchymal destruction, the direct sign of emphysema. Although quantitative and qualitative studies have shown that CT can allow distinguishing subtypes of emphysema, a widespread routine use of CT for the assessment of COPD in clinical practice cannot be currently foreseen due to radiation exposure and limited instrumental availability.

LUS can detect pleural-pulmonary pathologies. However, the use of LUS as an indication of underlying parenchymal lung disease, when the organ is still aerated, as in emphysema, is a new application.

This study is aimed at researching correlations among a pool of data deriving from ultrasonographic and tomographic evaluations of patients with panlobular or paraseptal emphysema, to improve the comprehension of acoustic information derived from ultrasound evaluation.

The study will not modify the diagnostic / therapeutic process of the enrolled patients, who will all have in common the CT evidence of panlobular or paraseptal emphysema.

Researchers will observe three defined population of patients at a single point (at the time of enrolment). All subjects will have CT evidence of panlobular or paraseptal emphysema. Patients will be recruited through three paths: 1) patients suffered from COPD, in follow-up at Pulmonary Medicine Units in Rome and Naples, with HRCT evidence of paraseptal or panlobular emphysema; 2) subjects who participate in the screening program for lung cancer in Rome, Naples and Acquaviva delle Fonti, and 3) patients with suspected/known lung cancer managed in all medical Units involved in this project.

All enrolled subjects 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 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. IOS is almost independent of patient cooperation and can test a larger patient range than spirometry alone including geriatric patients.

Study Type

Interventional

Enrollment (Estimated)

1628

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Acquaviva delle Fonti, Italy, 70021
        • Not yet recruiting
        • Ente Ecclesiastico, Ospedale Generale Regionale "F. Miulli"
        • Contact:
        • Contact:
        • Principal Investigator:
          • Riccardo Inchingolo, MD
        • Sub-Investigator:
          • Letizia Laera, MD
      • Naples, Italy, 80131
      • Rome, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Contact:
        • Contact:
        • Principal Investigator:
          • Riccardo Inchingolo, MD, PhD
        • Principal Investigator:
          • Andrea Smargiassi, MD, PhD
        • Sub-Investigator:
          • Maria Teresa Congedo, MD
        • Sub-Investigator:
          • Elisa Meacci, Prof., MD
      • Trento, Italy, 38123
        • Not yet recruiting
        • University of Trento
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giovanni Iacca, Prof., PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 who participate in the screening program for lung cancer with computed tomographic evidence of panlobular or paraseptal emphysema.
  • Outpatients / Inpatients with suspected/known lung cancer and computed tomographic evidence of panlobular or paraseptal emphysema.
  • Patients able to give written informed consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with pulmonary paraseptal or panlobular emphysema

Ultrasonographic findings will be obtained with clinical machines. Additionally, ultrasonographic scans as acquired with research platform will also be gathered.

LUS findings will be compared to chest computed tomographic findings. Post-processing image analysis of chest CT findings will be performed on images by using automated detection of potential emphysema systems.

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.
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.
Experimental: Healthy volunteers and participants without pulmonary emphysema

Ultrasonographic findings will be obtained with clinical machines. Additionally, ultrasonographic scans as acquired with research platform will also be gathered.

LUS findings will be compared to chest computed tomographic findings. Post-processing image analysis of chest CT findings will be performed on images by using automated detection of potential emphysema systems.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with ultrasonographic pattern of emphysema.
Time Frame: through study completion, an average of 2 year
To characterize ultrasonographic signs of paraseptal or panlobular emphysema, the measurement of the ultrasound backscattering-index, as a function of the transmitted frequency, will be perform.
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Università degli Studi di Trento
Miulli General Hospital
Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli

Investigators

  • Principal Investigator: Riccardo Inchingolo, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6855
  • PNRR-MCNT2-2023-12378311 (Other Grant/Funding Number: European Union - Next Generation EU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Researchers intend to communicate the trial results to participants, healthcare professionals, and other relevant groups through scientific publications and national and international conference proceedings. No individual participant data will be available.

Any document produced, including scientific publications relating to the research project will contain an explicit indication that the project is financed under the PNRR statement stating "funded by the European Union - Next Generation EU - PNRR M6C2 - Investment 2.1 Enhancement and strengthening of biomedical research in the NHS", the emblem of the Union European Union and the project code. The products will be made public through systems that allow immediate use by the public (for example open-access).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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