Clinical-ultrasonographic Assessment of Pulmonary Emphysema

NCT06533371 | Recruiting

• 2 other identifiers: 6855PNRR-MCNT2-2023-12378311
• Study Type: interventional
• Target: 1,628
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Emphysema; Pulmonary Emphysema

Keywords

Pulmonary emphysema; Emphysema; Lung ultrasound; Oscillometry; Quantitative analysis; Chest computed tomography; Early diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 2 year

Study Arms (2)

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.

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.

Diagnostic Test: Relationship between lung ultrasound and computed tomographic scan

Interventions

Relationship between lung ultrasound and computed tomographic scan DIAGNOSTIC_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.

Healthy volunteers and participants without pulmonary emphysema; Patients with pulmonary paraseptal or panlobular emphysema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Miulli General Hospital: collaborator
• Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli: collaborator
• Università degli Studi di Trento: collaborator

Study Sites (4)

Ente Ecclesiastico, Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, 70021, Italy

NOT YET RECRUITING

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

Napoli, 80131, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

University of Trento

Trento, 38123, Italy

NOT YET RECRUITING

Related Publications (12)

• 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.

  PMID: 37647701 BACKGROUND

• Wolfram 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.

  PMID: 36377189 BACKGROUND

• Demi 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.

  PMID: 35993596 BACKGROUND

• Mento 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.

  PMID: 36155147 BACKGROUND

• Mento 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.

  PMID: 34972265 BACKGROUND

• Guidi 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.

  PMID: 34216989 BACKGROUND

• Peschiera 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.

  PMID: 33940883 BACKGROUND

• Mento 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.

  PMID: 32873037 BACKGROUND

• Soldati 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.

  PMID: 30616416 BACKGROUND

• Occhipinti 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.

  PMID: 31122243 BACKGROUND

• Occhipinti 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.

  PMID: 29361243 BACKGROUND

• Veneroni 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.

  PMID: 38843786 BACKGROUND

MeSH Terms

Conditions

Emphysema; Pulmonary Emphysema; Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Riccardo Inchingolo, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Inchingolo, MD, PhD

CONTACT

011390630156062; riccardo.inchingolo@policlinicogemelli.it

Andrea Smargiassi, MD, PhD

CONTACT

011390630156062; andrea.smargiassi@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 1, 2024
• Study Start: September 4, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)