Functional Magnetic Resonance Imaging of the Lung to Detect Regional Reversibility and Progression in Interstitial Lung Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Identification of ILD Subtypes Using Baseline MRI Metrics
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Identification of ILD Subtypes Using Baseline MRI Metrics
Time Frame: Baseline (first MRI scan)
Assess whether baseline MRI metrics can accurately differentiate subtypes of interstitial lung disease, using clinician diagnosis (based on multidisciplinary discussion) as the reference standard.
Secondary Outcomes
- Correlation of Longitudinal MRI Changes with Disease Progression(From enrollment (baseline MRI) through up to 1-year after enrollment; follow-up assessments will only be performed if clinically indicated.)
Investigators
Hans-Ulrich Kauczor
Medical Director of Diagnostic and Interventional Radiology at the Heidelberg University Hospital
University Hospital Heidelberg