Interstitial Lung Diseases (ILD)IMPACT-ILDNCT07300696
Functional MRI for Monitoring Progression and Assessing Trends in ILD
A study testing Lung MRI Protocol with Functional and Contrast-Enhanced Sequences in people with Interstitial Lung Diseases (ILD), run by University Hospital Heidelberg at 2 sites in Germany.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Diseases (ILD)
- What is being tested?
- Lung MRI Protocol with Functional and Contrast-Enhanced Sequences
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Nov 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 1 recruiting
- Recruiting
Thoraxklink Heidelberg - Universitätsklinikum Heidelberg
Heidelberg, 69126
Carley Stewart, PhD, +4962215636823, Carley.Stewart@med.uni-heidelberg.de
- Active, not recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
About this study
Official title: 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.
- Conditions
- Interstitial Lung Diseases (ILD)
- Being tested
- Lung MRI Protocol with Functional and Contrast-Enhanced Sequences
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung MRI Protocol with Functional and Contrast-Enhanced SequencesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| MRI Examination Protocol | Experimental | Not described Receives: Diagnostic Test: Lung MRI Protocol with Functional and Contrast-Enhanced Sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment (baseline MRI) through up to 1-year after enrollment; follow-up assessments will only be performed if clinically indicated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start20 Nov 2025
- Primary completionFeb 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Diseases (ILD)Studies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Lung Research, Thoraxklinik-Heidelberg gGmbH, University Hospital Schleswig-Holstein
- Responsible party
- Principal investigator, Hans-Ulrich Kauczor, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300696
- Sponsor's protocol ID
- S-296/2024
- Acronym
- IMPACT-ILD
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging of the Lung to Detect Regional Reversibility and Progression in Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07300696
- Acronym / sponsor ID
- IMPACT-ILD / S-296/2024
- Conditions
- Interstitial Lung Diseases (ILD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- German Center for Lung Research, Thoraxklinik-Heidelberg gGmbH, University Hospital Schleswig-Holstein
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Examination Protocol | Experimental | Diagnostic Test: Lung MRI Protocol with Functional and Contrast-Enhanced Sequences |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung MRI Protocol with Functional and Contrast-Enhanced SequencesParticipants 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. | Diagnostic test | MRI Examination Protocol |
Primary outcome
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.
1 secondary outcome
Correlation of Longitudinal MRI Changes with Disease Progression
Time frame: From enrollment (baseline MRI) through up to 1-year after enrollment; follow-up assessments will only be performed if clinically indicated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thoraxklink Heidelberg - Universitätsklinikum Heidelberg
Heidelberg, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung MRI Protocol with Functional and Contrast-Enhanced Sequences in people with Interstitial Lung Diseases (ILD), run by University Hospital Heidelberg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of ILD Subtypes Using Baseline MRI Metrics (time frame: Baseline (first MRI scan)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.