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Functional MRI for Monitoring Progression and Assessing Trends in ILD

ConditionInterstitial Lung Diseases (ILD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

The main objective of this study is to investigate the utility of functional MRI to differentiate, characterize, and monitor subgroups of ILD. This can be broken down into three specific objectives:

Determine if ILD features observed on high-resolution computed tomography (HRCT), such as ground glass opacities (GGO), are functionally different.

Analyse MRI metrics within each subgroup to determine whether these metrics distinguish different ILDs.

Assess MRI metrics longitudinally to see if these parameters change with disease progression, stability, or reversibility.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical indication for a routine HRCT because of either newly diagnosed idiopathic pulmonary fibrosis (IPF) or hypersensitivity pneumonitis (HP) or idiopathic non-specific interstitial pneumonia (iNSIP), suspected diagnosis, or follow-up

Capacity to consent

Ability to participate fully in the study (defined by the ability to lie still for the duration of imaging)

Disqualifiers

Pregnancy and breast feeding

Persons under the age of 18 and persons not able to give informed consent

Any medical conditions that could hinder the ability to adhere to the protocol

Any MRI contraindication, including previous allergic reactions to Gd-based MRI contrast material and renal dysfunction (eGFR < 30 ml min/1,73 m2)

Trial design

Design model

Single group

Treatments tested in this trial

  • Lung MRI Protocol with Functional and Contrast-Enhanced Sequences

    Diagnostic test

    Participants will undergo a lung MRI protocol consisting of structural imaging, non-contrast functional imaging, and contrast-enhanced imaging. Some sequences are custom-developed and performed during free breathing to accommodate patients with respiratory limitations.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: MRI Examination ProtocolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Identification of ILD Subtypes Using Baseline MRI Metrics

Assess whether baseline MRI metrics can accurately differentiate subtypes of interstitial lung disease, using clinician diagnosis (based on multidisciplinary discussion) as the reference standard.

Time frame
Baseline (first MRI scan)

Secondary outcomes

1

Correlation of Longitudinal MRI Changes with Disease Progression

Evaluate changes in MRI metrics over time and their correlation with ILD progression, using ATS/ERS/JRS/ALAT criteria.

Time frame
From enrollment (baseline MRI) through up to 1-year after enrollment; follow-up assessments will only be performed if clinically indicated.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Heidelberg

Lead sponsor

German Center for Lung Research

Collaborator

Thoraxklinik-Heidelberg gGmbH

Collaborator

University Hospital Schleswig-Holstein

Collaborator

Source ClinicalTrials.gov
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