Assessing lung health using ultrasound in emphysema patients

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

This study is testing if lung ultrasound can help doctors better understand lung health in people with emphysema compared to healthy individuals and those with lung cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1628 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Drugs / interventions: radiation
• Locations: 4 sites (Acquaviva delle Fonti and 3 other locations)
• Trial ID: NCT06533371 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to explore the correlations between lung ultrasonographic (LUS) patterns and high-resolution computed tomography (HRCT) findings in patients with panlobular or paraseptal emphysema. It will involve comparing LUS data from COPD patients, lung cancer screening participants, and those with suspected lung cancer against healthy volunteers. The study seeks to enhance understanding of how ultrasound can indicate underlying lung conditions, particularly when the lungs are still aerated. By analyzing these correlations, researchers hope to improve diagnostic accuracy and patient management.

Who should consider this trial

Good fit: Ideal candidates include outpatients and inpatients with chronic obstructive pulmonary disease or lung cancer who have CT evidence of panlobular or paraseptal emphysema.

Not a fit: Patients who are pregnant, pediatric, or unable to provide informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic techniques for emphysema and related lung conditions, enhancing patient care.

How similar studies have performed: While the use of lung ultrasound in assessing thoracic diseases is established, this specific application in emphysema is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Acquaviva delle Fonti and 3 other locations

• Ente Ecclesiastico, Ospedale Generale Regionale "F. Miulli" — Acquaviva delle Fonti, Italy (NOT_YET_RECRUITING)
• A.O.R.N. "A. Cardarelli" — Naples, Italy (NOT_YET_RECRUITING)
• Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (RECRUITING)
• University of Trento — Trento, Italy (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Riccardo Inchingolo, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Riccardo Inchingolo, MD, PhD

Conditions: Emphysema, Pulmonary Emphysema, Pulmonary emphysema, Lung ultrasound, Oscillometry, Quantitative analysis, Chest computed tomography, Early diagnosis