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RecruitingNCT07300696IMPACT-ILDUpdated Dec 24, 2025

Functional MRI for Monitoring Progression and Assessing Trends in ILD

An interventional study of Lung MRI Protocol with Functional and Contrast-Enhanced Sequences in Interstitial Lung Diseases (ILD), sponsored by University Hospital Heidelberg. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Interstitial Lung Diseases (ILD)
03

In context

Lung Diseases, Interstitial

646 studies on the registry are indexed under Lung Diseases, Interstitial; 237 are open to participants now.

This study's planned enrollment of 200 is above the median of 54 across 355 interventional studies indexed under Lung Diseases, Interstitial.

Browse Lung Diseases, Interstitial studies →

Lead sponsor

University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    MRI Examination Protocol

    Diagnostic Test: Lung MRI Protocol with Functional and Contrast-Enhanced Sequences

Interventions

  • Diagnostic testLung 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.

06

What researchers measure

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.

07

Study locations

1 of 2 sites recruiting
  • Thoraxklink Heidelberg - Universitätsklinikum Heidelberg
    Heidelberg, 69126, Germany
    Recruiting
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
    Kiel, 24105, Germany
    Active, not recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07300696
Lead sponsor
University Hospital Heidelberg
Collaborators
German Center for Lung Research, Thoraxklinik-Heidelberg gGmbH, University Hospital Schleswig-Holstein
Responsible party
Hans-Ulrich Kauczor (Medical Director of Diagnostic and Interventional Radiology at the Heidelberg University Hospital, University Hospital Heidelberg) — Principal investigator
First posted
Dec 24, 2025
Start date
Nov 20, 2025
Primary completion
Feb 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Dec 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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