Functional MRI for Monitoring Progression and Assessing Trends in ILD

NCT07300696 | Recruiting

• 1 other identifier: S-296/2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Interstitial Lung Diseases (ILD)

Outcome Measures

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.

  Baseline (first MRI scan)

Secondary Outcomes (1)

• 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.

Study Arms (1)

MRI Examination Protocol

EXPERIMENTAL

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

Interventions

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.

MRI Examination Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• German Center for Lung Research: collaborator
• Thoraxklinik-Heidelberg gGmbH: collaborator
• University Hospital Schleswig-Holstein: collaborator
• University Hospital Heidelberg: lead

Study Sites (2)

Thoraxklink Heidelberg - Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Diagnostic and Interventional Radiology at the Heidelberg University Hospital

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 24, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

DE (2)