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Functional MRI for Monitoring Progression and Assessing Trends in ILD

NCT ID: NCT07300696

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Interstitial Lung Diseases (ILD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI Examination Protocol

Group Type EXPERIMENTAL

Lung MRI Protocol with Functional and Contrast-Enhanced Sequences

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Center for Lung Research

OTHER

Sponsor Role collaborator

Thoraxklinik-Heidelberg gGmbH

OTHER

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Hans-Ulrich Kauczor

Medical Director of Diagnostic and Interventional Radiology at the Heidelberg University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thoraxklink Heidelberg - Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status ACTIVE_NOT_RECRUITING

Countries

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Germany

Facility Contacts

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Carley Stewart, PhD

Role: primary

Other Identifiers

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S-296/2024

Identifier Type: -

Identifier Source: org_study_id