Can scans replace breathing tests to monitor lung scarring?
NCT ID NCT05492994
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This study follows 31 people with progressive fibrosing interstitial lung disease (PF-ILD) for one year. Researchers compare imaging scans (CT and MRI) with standard breathing tests to see which method best tracks lung damage over time. The goal is to find better ways to measure disease progression for use in future drug trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help develop better imaging tools to monitor lung disease progression and improve future clinical trials.
- What could go wrong
- This is a small observational study, not a treatment trial. The imaging methods may not prove more useful than standard lung function tests.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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31 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the study. 2. Patients with a documented diagnosis of Progressive Fibrosing Interstitial Lung Disease (PF-ILD) including Idiopathic Pulmonary Fibrosis (IPF), with Usual Interstitial Pneumonia (UIP) or probable UIP chest Computer Tomography (CT) pattern and no anti-fibrotic treatment (nintedanib or pirfenidone) at baseline and previously (treatment-naive regarding Standard of Care (SoC)) 3. Male or female patients aged ≥ 40 years when signing the informed consent. 4. Forced Vital Capacity (FVC) ≥ 45% predicted of normal reviewed at Visit 1. 5. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) corrected for Haemoglobin ≥ 25% of predicted normal reviewed at Visit 1. 6. Body mass index (BMI) \<=30 kg/m2 reviewed at Visit 1. 7. Glomerular filtration rate (GFR) ≥30 ml/min reviewed at Visit 1. 8. Supportive Thyroid-Stimulating Hormone (TSH) evaluation for all participants \>60 years and/or history of thyroid disease according to local standard procedures at Visit 1. Exclusion Criteria: 1. Significant pulmonary disease other than PF-ILD or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in any of the following: * Put the patient at risk because of participation in the study * Influence the results of the study * Cause concern regarding the patient's ability to participate in the study Patients with a history of a documented Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection will be excluded if lung changes due to the infection have been observed at screening (on discretion of the investigator). 2. Any documented active or suspected malignancy or history of malignancy on discretion of the investigator. 3. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the accurate assessment of endpoints of the study. 4. Patients not able to understand or follow study procedures or patients not expected to comply with the protocol requirements or not expected to complete the study as scheduled (e.g., chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable study participant). 5. Previous enrolment in this study. 6. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). 7. Women who are pregnant, nursing, or who plan to become pregnant while in the study. Women of childbearing potential1 not willing or able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2). A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol. 8. Life expectancy for disease other than Interstitial Lung Disease (ILD) \<2.5 years (investigator assessment) Further exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medizinische Hochschule Hannover
Hanover, 30625, Germany
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