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

NCT06844331 | Enrolling By Invitation DMC

• 1 other identifier: S-20220036
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibrosing Interstitial Lung Diseases; Thoracic Ultrasound

Keywords

Fibrosing interstitial lung diseases; Thoracic ultrasound

Outcome Measures

Primary Outcomes (1)

• Changes in Thoracic ultrasound/ ultrasound (TUS/US) measurments over 12 months in patients with F-ILD.

  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.

  12 months. The investigator group will examine patients in baseline (Day 0), after 6 months (day 180) and after 12 months (day 365).

Secondary Outcomes (1)

• Measure the association and variability and observer variabilty.

  12 months. The investigator group will examine patients in baseline (Day 0), after 6 months (day 180) and after 12 months (day 365).

Study Arms (1)

F-ILD patients

The investigators including the patients with fibrosing interstitial lunge disease (F-ILD) as cohort. Both the patients with idiopathic interstitial lung diseases and progressive pulmnoary fibrosis will include.

Device: Thoracic ultrasound

Interventions

Thoracic ultrasound DEVICE

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

Also known as: Ultrasound

F-ILD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited from South Danish Center for ILD (SCILS) under the Department of Respiratory Medicine at Odense University Hospital, Denmark. SCILS receive patients suspected for ILD from both the primary sector within their local areas as well as from all other hospital departments within the region. Annually SCILS asses approximate 1.500 outpatient clinic patients, and 400 new patients referred for assessment. Respiratory physician that work in SCILS informed eligible patients regarding project and the PhD student contact them afterwards.

You may qualify if:

• 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.

You may not qualify if:

• Patients not willing to or able to give informed consent.
• Acute exacerbation in F-ILD \< 4 weeks.
• Pregnant and breastfeeding mothers

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Southern Denmark, 5000, Denmark

Location

Related Publications (41)

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MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jesper R Davidsen, MD,PhD

  Department of Respiratory Medicine, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 25, 2025
• Study Start: October 21, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)