NCT06533371 Clinical-ultrasonographic Assessment of Pulmonary Emphysema
| NCT ID | NCT06533371 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Emphysema |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,628 participants |
| Start Date | 2024-09-04 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,628 participants in total. It began in 2024-09-04 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Riccardo Inchingolo, MD, PhD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06533371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Emphysema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06533371 currently recruiting?
Yes, NCT06533371 is actively recruiting participants. Contact the research team at riccardo.inchingolo@policlinicogemelli.it for enrollment information.
Where is the NCT06533371 trial being conducted?
This trial is being conducted at Acquaviva delle Fonti, Italy, Naples, Italy, Rome, Italy, Trento, Italy.
Who is sponsoring the NCT06533371 clinical trial?
NCT06533371 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Riccardo Inchingolo, MD, PhD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 1,628 participants.