Functional MRI for Monitoring Progression and Assessing Trends in ILD (IMPACT-ILD)

Functional Magnetic Resonance Imaging of the Lung to Detect Regional Reversibility and Progression in Interstitial Lung Disease

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 Overview

• Status: Recruiting
• Conditions: Interstitial Lung Diseases (ILD)
• Intervention / Treatment: Diagnostic test: Lung MRI Protocol with Functional and Contrast-Enhanced Sequences

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69126
    • Recruiting
    • Thoraxklink Heidelberg - Universitätsklinikum Heidelberg
    • Contact: Carley Stewart, PhD; Phone Number: +4962215636823; Email: Carley.Stewart@med.uni-heidelberg.de
  • Kiel, Germany, 24105
    • Active, not recruiting
    • Universitatsklinikum Schleswig-Holstein, Campus Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI Examination Protocol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (first MRI scan)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Collaborators: University Hospital Schleswig-Holstein; German Center for Lung Research; Thoraxklinik-Heidelberg gGmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: S-296/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No