Functional MRI for Monitoring Progression and Assessing Trends in ILD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung MRI Protocol with Functional and Contrast-Enhanced Sequences.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Diseases (ILD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Functional Magnetic Resonance Imaging of the Lung to Detect Regional Reversibility and Progression in Interstitial Lung Disease
Overview
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.
Interventions
- Diagnostic test Lung MRI Protocol with Functional and Contrast-Enhanced Sequences
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.
Primary outcome measures
- Identification of ILD Subtypes Using Baseline MRI Metrics [Time frame: Baseline (first MRI scan)]
Secondary outcome measures (1)
- Correlation of Longitudinal MRI Changes with Disease Progression [Time frame: From enrollment (baseline MRI) through up to 1-year after enrollment; follow-up assessments will only be performed if clinically indicated.]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Germany · 2 centers
- Thoraxklink Heidelberg - Universitätsklinikum Heidelberg — Heidelberg
- Universitätsklinikum Schleswig-Holstein, Campus Kiel — Kiel
Identifiers
NCT: NCT07300696 · S-296/2024