An interventional study of Relationship between lung ultrasound and computed tomographic scan in Emphysema and Pulmonary Emphysema, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 4 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
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.
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.
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 1,628 is above the median of 60 across 245 interventional studies indexed under Emphysema.
Browse Emphysema studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, 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.
Number of participants with ultrasonographic pattern of emphysema.
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.
Time frame: through study completion, an average of 2 year
Plan to share: No — 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).
Started Sep 2024 (actual). Primary completion is estimated for Sep 2026, 24 months after the start.
Of 40 non-industry interventional studies with no phase under Emphysema, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 58. This study's planned 24 months is below that.
Counting every sponsor, half of 60 studies reached it within 37 months; a quarter within 22 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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