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Enrolling by invitation Observational

Ultrasound Applicability in the Assessment of Patients With Fibrosing Interstitial Lung Disease

NCT06844331 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2024-10-21
Last updated
2025-08-07

Condition(s) studied

Fibrosing Interstitial Lung DiseasesThoracic Ultrasound

Investigational drug(s) / intervention(s)

Thoracic ultrasound

Thoracic ultrasound: The investigators want to investigate that TUS/US can use to identify and to monitir the disease progression in the patients with F-ILD

Study summary

In this study the investigators want to examine the different ultrasound techniques to assess the patients with lung fibrosis.

The investigators want to followup these patients in 1 year to see the changes in lungs, pleura, diaphragm and measurments of overarm and thigh muscles to see that the investigators can identify the patients with lung fibrosis with this methods and monitor the progression.

Now a days the CT scan in the lungs needs to monitor these participants, but the investigators want to see the ultrasound can use insted for CT scanning to minitor these pateints.

These patient group has very bad prognosis, so it is necessary to identify these patients as early as possible to treatments.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients must be over 18 years. * Diagnosis of IPF obtained on a multidisciplinary team conference . * Diagnosis of PPF according to 2022 ATS/ERS/JRS/ALAT Clinical Practice Guideline. * Ability for subject to comply with the requirements of the study. * Informed consent. Exclusion Criteria: * Patients not willing to or able to give informed consent. * Acute exacerbation in F-ILD \< 4 weeks. * Pregnant and breastfeeding mothers

Primary outcome measure(s)

  • Changes in Thoracic ultrasound/ ultrasound (TUS/US) measurments over 12 months in patients with F-ILD. — 12 months. The investigator group will examine patients in baseline (Day 0), after 6 months (day 180) and after 12 months (day 365).
    The investigators want to examine that TUS/US modalities such as B line artifacts (BLA) , interstitial syndrom (IS), pleural abnormalities (PA), diapgragm excursion (DE), lung ultarsound share wave elastography (LUSWE), appendicular lean mass (ALM) are clinically valuable, both individually and in combination for identifying F-ILD and monitoring disease activity. These modalities are expected to predict FVC (%), diffusion capacity of the lung for carbon monoxide (DLCO%), HRCT findings, and clinical symptoms. The invstigators hypothized that F-ILD patients with severe disease are present increased number of BLAs( more than 10 B-lines in minimum 2 lung zones), increased pleural irregularities (in milimeters), decreased DE (DE in milimeters), higher LUSWE velocities (meters and second to m/s), and lower ALM values (Kilogram and meters combined to report ALM kg/m2). The investigators wan to further these modalities serve as dynamic indicators of F-ILD disease activity over time.

Trial sites (1)

FacilityCityRegionStatus
Odense University Hospital Odense Southern Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06844331 on ClinicalTrials.gov ↗ ← All trials in Denmark