EmphysemaESCULAPIONCT06533371
Clinical-ultrasonographic Assessment of Pulmonary Emphysema
A study testing Relationship between lung ultrasound and computed tomographic scan in people with Emphysema and Pulmonary Emphysema, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emphysema, Pulmonary Emphysema
- What is being tested?
- Relationship between lung ultrasound and computed tomographic scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,628 participants
- Where
- 4 sitesItaly
- Study dates
- 4 Sep 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- pregnancy.
- Pediatric population.
- Patients unable to express written informed consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Not yet recruiting
Ente Ecclesiastico, Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, 70021
Riccardo Inchingolo, MD, +390803054111, r.inchingolo@miulli.it
Miriana Del Mastro, +390803054203, m.delmastro@miulli.it
- Not yet recruiting
A.O.R.N. "A. Cardarelli"
Naples, 80131
Carlo Santoriello, MD, +390817471111, carlo.santoriello@aocardarelli.it
Marcella Abbate, +39817473950, marcella.abbate@aocardarelli.it
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Riccardo Inchingolo, MD, PhD, +390630156062, riccardo.inchingolo@policlinicogemelli.it
Andrea Smargiassi, MD, PhD, +390630156062, andrea.smargiassi@policlinicogemelli.it
- Not yet recruiting
University of Trento
Trento, 38123
Giovanni Iacca, Prof., PhD, +390461285220, giovanni.iacca@unitn.it
Mirella Collini, +390461281634, mirella.collini@unitn.it
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Emphysema, Pulmonary Emphysema
- Being tested
- Relationship between lung ultrasound and computed tomographic scan
- Keywords
- Pulmonary emphysema, Emphysema, Lung ultrasound, Oscillometry, Quantitative analysis, Chest computed tomography, Early diagnosis
- Medical subject headings
- Emphysema, Pulmonary Emphysema, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship between lung ultrasound and computed tomographic scanDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pulmonary paraseptal or panlobular emphysema | Experimental | 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. Receives: Diagnostic Test: Relationship between lung ultrasound and computed tomographic scan |
| Healthy volunteers and participants without pulmonary emphysema | Experimental | 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. Receives: Diagnostic Test: Relationship between lung ultrasound and computed tomographic scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start4 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,628 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Miulli General Hospital, Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli, Università degli Studi di Trento
- Responsible party
- Sponsor
- Investigators
- Riccardo Inchingolo, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533371
- Sponsor's protocol ID
- 6855
- Other IDs
- PNRR-MCNT2-2023-12378311
- Acronym
- ESCULAPIO
- Status last verified
- May 2026
- First submitted
- 25 Jul 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
Mento F, Perini M, Malacarne C, Demi L. Ultrasound multifrequency strategy to estimate the lung surface roughness, in silico and in vitro results. Ultrasonics. 2023 Dec;135:107143. doi: 10.1016/j.ultras.2023.107143. Epub 2023 Aug 24.
PubMed 37647701Wolfram F, Miller D, Demi L, Verma P, Moran CM, Walther M, Mathis G, Prosch H, Kollmann C, Jenderka KV. Best Practice Recommendations for the Safe use of Lung Ultrasound. Ultraschall Med. 2023 Oct;44(5):516-519. doi: 10.1055/a-1978-5575. Epub 2022 Nov 14.
PubMed 36377189Demi L, Wolfram F, Klersy C, De Silvestri A, Ferretti VV, Muller M, Miller D, Feletti F, Welnicki M, Buda N, Skoczylas A, Pomiecko A, Damjanovic D, Olszewski R, Kirkpatrick AW, Breitkreutz R, Mathis G, Soldati G, Smargiassi A, Inchingolo R, Perrone T. New International Guidelines and Consensus on the Use of Lung Ultrasound. J Ultrasound Med. 2023 Feb;42(2):309-344. doi: 10.1002/jum.16088. Epub 2022 Aug 22.
PubMed 35993596Mento F, Khan U, Faita F, Smargiassi A, Inchingolo R, Perrone T, Demi L. State of the Art in Lung Ultrasound, Shifting from Qualitative to Quantitative Analyses. Ultrasound Med Biol. 2022 Dec;48(12):2398-2416. doi: 10.1016/j.ultrasmedbio.2022.07.007. Epub 2022 Sep 23.
PubMed 36155147Mento F, Demi L. Dependence of lung ultrasound vertical artifacts on frequency, bandwidth, focus and angle of incidence: An in vitro study. J Acoust Soc Am. 2021 Dec;150(6):4075. doi: 10.1121/10.0007482.
PubMed 34972265Guidi F, Demi L, Tortoli P. Experimental and simulation study of harmonic components generated by plane and focused waves. Ultrasonics. 2021 Sep;116:106504. doi: 10.1016/j.ultras.2021.106504. Epub 2021 Jun 22.
PubMed 34216989Peschiera E, Mento F, Demi L. Numerical study on lung ultrasound B-line formation as a function of imaging frequency and alveolar geometries. J Acoust Soc Am. 2021 Apr;149(4):2304. doi: 10.1121/10.0003930.
PubMed 33940883Mento F, Demi L. On the influence of imaging parameters on lung ultrasound B-line artifacts, in vitro study. J Acoust Soc Am. 2020 Aug;148(2):975. doi: 10.1121/10.0001797.
PubMed 32873037Soldati G, Demi M, Smargiassi A, Inchingolo R, Demi L. The role of ultrasound lung artifacts in the diagnosis of respiratory diseases. Expert Rev Respir Med. 2019 Feb;13(2):163-172. doi: 10.1080/17476348.2019.1565997. Epub 2019 Jan 10.
PubMed 30616416Occhipinti M, Paoletti M, Bartholmai BJ, Rajagopalan S, Karwoski RA, Nardi C, Inchingolo R, Larici AR, Camiciottoli G, Lavorini F, Colagrande S, Brusasco V, Pistolesi M. Spirometric assessment of emphysema presence and severity as measured by quantitative CT and CT-based radiomics in COPD. Respir Res. 2019 May 23;20(1):101. doi: 10.1186/s12931-019-1049-3.
PubMed 31122243Occhipinti M, Paoletti M, Bigazzi F, Camiciottoli G, Inchingolo R, Larici AR, Pistolesi M. Emphysematous and Nonemphysematous Gas Trapping in Chronic Obstructive Pulmonary Disease: Quantitative CT Findings and Pulmonary Function. Radiology. 2018 May;287(2):683-692. doi: 10.1148/radiol.2017171519. Epub 2018 Jan 23.
PubMed 29361243Veneroni C, Gobbi A, Pompilio PP, Dellaca R, Fasola S, La Grutta S, Leyva A, Porszasz J, Stornelli SR, Fuso L, Valach C, Breyer-Kohansal R, Breyer MK, Hartl S, Contu C, Inchingolo R, Hodgdon K, Kaminsky DA. Reference Equations for Within-Breath Respiratory Oscillometry in White Adults. Respiration. 2024;103(9):521-534. doi: 10.1159/000539532. Epub 2024 Jun 7.
PubMed 38843786
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pulmonary EmphySema: the Clinical -ULtrasonographic APproach to chronIc Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06533371
- Acronym / sponsor ID
- ESCULAPIO / 6855
- Conditions
- Emphysema, Pulmonary Emphysema
- Keywords
- Pulmonary emphysema, Emphysema, Lung ultrasound, Oscillometry, Quantitative analysis, Chest computed tomography, Early diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,628 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Miulli General Hospital, Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli, Università degli Studi di Trento
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary paraseptal or panlobular emphysema | Experimental | Diagnostic Test: Relationship between lung ultrasound and computed tomographic scanUltrasonographic 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. |
| Healthy volunteers and participants without pulmonary emphysema | Experimental | Diagnostic Test: Relationship between lung ultrasound and computed tomographic scanUltrasonographic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- pregnancy.
- Pediatric population.
- Patients unable to express written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relationship between lung ultrasound and computed tomographic scanUltrasonographic 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. | Diagnostic test | Healthy volunteers and participants without pulmonary emphysema, Patients with pulmonary paraseptal or panlobular emphysema |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 37647701Mento F, Perini M, Malacarne C, Demi L. Ultrasound multifrequency strategy to estimate the lung surface roughness, in silico and in vitro results. Ultrasonics. 2023 Dec;135:107143. doi: 10.1016/j.ultras.2023.107143. Epub 2023 Aug 24.
- Background: PubMed 36377189Wolfram F, Miller D, Demi L, Verma P, Moran CM, Walther M, Mathis G, Prosch H, Kollmann C, Jenderka KV. Best Practice Recommendations for the Safe use of Lung Ultrasound. Ultraschall Med. 2023 Oct;44(5):516-519. doi: 10.1055/a-1978-5575. Epub 2022 Nov 14.
- Background: PubMed 35993596Demi L, Wolfram F, Klersy C, De Silvestri A, Ferretti VV, Muller M, Miller D, Feletti F, Welnicki M, Buda N, Skoczylas A, Pomiecko A, Damjanovic D, Olszewski R, Kirkpatrick AW, Breitkreutz R, Mathis G, Soldati G, Smargiassi A, Inchingolo R, Perrone T. New International Guidelines and Consensus on the Use of Lung Ultrasound. J Ultrasound Med. 2023 Feb;42(2):309-344. doi: 10.1002/jum.16088. Epub 2022 Aug 22.
- Background: PubMed 36155147Mento F, Khan U, Faita F, Smargiassi A, Inchingolo R, Perrone T, Demi L. State of the Art in Lung Ultrasound, Shifting from Qualitative to Quantitative Analyses. Ultrasound Med Biol. 2022 Dec;48(12):2398-2416. doi: 10.1016/j.ultrasmedbio.2022.07.007. Epub 2022 Sep 23.
- Background: PubMed 34972265Mento F, Demi L. Dependence of lung ultrasound vertical artifacts on frequency, bandwidth, focus and angle of incidence: An in vitro study. J Acoust Soc Am. 2021 Dec;150(6):4075. doi: 10.1121/10.0007482.
- Background: PubMed 34216989Guidi F, Demi L, Tortoli P. Experimental and simulation study of harmonic components generated by plane and focused waves. Ultrasonics. 2021 Sep;116:106504. doi: 10.1016/j.ultras.2021.106504. Epub 2021 Jun 22.
- Background: PubMed 33940883Peschiera E, Mento F, Demi L. Numerical study on lung ultrasound B-line formation as a function of imaging frequency and alveolar geometries. J Acoust Soc Am. 2021 Apr;149(4):2304. doi: 10.1121/10.0003930.
- Background: PubMed 32873037Mento F, Demi L. On the influence of imaging parameters on lung ultrasound B-line artifacts, in vitro study. J Acoust Soc Am. 2020 Aug;148(2):975. doi: 10.1121/10.0001797.
- Background: PubMed 30616416Soldati G, Demi M, Smargiassi A, Inchingolo R, Demi L. The role of ultrasound lung artifacts in the diagnosis of respiratory diseases. Expert Rev Respir Med. 2019 Feb;13(2):163-172. doi: 10.1080/17476348.2019.1565997. Epub 2019 Jan 10.
- Background: PubMed 31122243Occhipinti M, Paoletti M, Bartholmai BJ, Rajagopalan S, Karwoski RA, Nardi C, Inchingolo R, Larici AR, Camiciottoli G, Lavorini F, Colagrande S, Brusasco V, Pistolesi M. Spirometric assessment of emphysema presence and severity as measured by quantitative CT and CT-based radiomics in COPD. Respir Res. 2019 May 23;20(1):101. doi: 10.1186/s12931-019-1049-3.
- Background: PubMed 29361243Occhipinti M, Paoletti M, Bigazzi F, Camiciottoli G, Inchingolo R, Larici AR, Pistolesi M. Emphysematous and Nonemphysematous Gas Trapping in Chronic Obstructive Pulmonary Disease: Quantitative CT Findings and Pulmonary Function. Radiology. 2018 May;287(2):683-692. doi: 10.1148/radiol.2017171519. Epub 2018 Jan 23.
- Background: PubMed 38843786Veneroni C, Gobbi A, Pompilio PP, Dellaca R, Fasola S, La Grutta S, Leyva A, Porszasz J, Stornelli SR, Fuso L, Valach C, Breyer-Kohansal R, Breyer MK, Hartl S, Contu C, Inchingolo R, Hodgdon K, Kaminsky DA. Reference Equations for Within-Breath Respiratory Oscillometry in White Adults. Respiration. 2024;103(9):521-534. doi: 10.1159/000539532. Epub 2024 Jun 7.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riccardo Inchingolo, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relationship between lung ultrasound and computed tomographic scan in people with Emphysema and Pulmonary Emphysema, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Inchingolo, MD, PhD (011390630156062, riccardo.inchingolo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with ultrasonographic pattern of emphysema. (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533371, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.