- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05914506
Hyperpolarized 129-Xenon MRI in Fibrosing Interstitial Lung Disease
Study Overview
Status
Intervention / Treatment
Detailed Description
Fibrosing interstitial lung diseases (F-ILD) represent a heterogeneous disease category involving several disease entities with different clinical, radiological, and histological characteristics. The common denominator for F-ILD patients is similarities regarding development of scarring of the lungs. Idiopathic pulmonary fibrosis (IPF) is the prototype, and all patients will eventually suffer from irreversible progression. In other type of F-ILD, a proportion of patients will also develop symptom worsening, treatment resistance towards immunomodulatory therapy, a decline in lung physiological parameters, worsening of radiologic findings and irreversible self-sustaining progression of pulmonary fibrosis i.e., a phenotype of progressive pulmonary fibrosis (PPF), defined by worsening of symptoms, lung physiology and radiology within 12 months Chest High Resolution Computed Tomography (HRCT) is considered the golden standard to diagnose and quantify the type and extent of pulmonary fibrosis. Extent of fibrosis and specific features like traction bronchiectasis and honeycombing seem in some disease to be associated with a worse outcome. However, findings do not always correspond to disease severity or disease course, and at later stages, HRCT is limited in proving the progression of the disease. Identifying progression is currently based on a decrease in forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), worsening of symptoms or progression of radiologic features (Table 1). Identification of radiologic biomarkers for progression will allow to better support treatment decisions and inform patients. Patients with F-ILD often suffer from a high burden of comorbidities, including ischemic heart disease, congestive heart failure, and pulmonary hypertension. It is currently unknown if these is solely associated to common risk factors like smoking and age, or could be due to fibrosis developing in the myocardium. Furthermore, it is not well described if the development of a restrictive lung physiology plays a role and affects cardiac physiology.
This study proposes that MR (magnetic resonance) Imaging with hyperpolarized 129Xenon will be able to detect subtle, regional dysfunction of the gas exchange of the lungs in patients with F-ILDs at a higher level of sensitivity than currently applied techniques. Utilizing the improved sensitivity of the hyperpolarized xenon MRI the study aims to improve the diagnostic distinction between the different subtypes of F-ILDs and additionally point-out MR biomarkers to be assess F-ILD severity, progression, and potential treatment response. Simultaneously with the hyperpolarized 129Xe scans, imaging of myocardial strain and ejection fraction is performed. In addition, a Gadolinium Based Contrast Agent (GBCA) is administered to evaluate the degree of myocardial fibrous tissue and lung perfusion. Thus, the impact of thoracic restrictive physiology on the heart can be detected and quantified.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mattias H. Kristensen, MD
- Phone Number: +4525216724
- Email: mattias.kristensen@clin.au.dk
Study Locations
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Aarhus, Denmark, 8200
- Aarhus University, Department of Clinical Medicine, MR Research Centre
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Contact:
- Mattias H. Kristensen, MD
- Phone Number: +4525216724
- Email: mattias.kristensen@clin.au.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Informed signed consent
- Age 18-90
- Pre-menopausal women must be confirmed non-pregnant by an onsite test.
- Patients diagnosed with IPF or fibrotic ILD who fulfills PPF criteria, and are prescribed antifibrotic treatment.
- Cognitively able to understand and participate in the study
Exclusion Criteria:
Contraindications for MRI:
- Pacemaker, neurostimulator or cochlear implant
- Metal foreign bodies such as fragments and irremovable piercings
- Unsafe medical implants (safety of heart valves, hips and the like must be confirmed)
- Intrathoracic clips or coils
- Cardiac pacemakers
- Claustrophobia
- Largest circumference including arms > 160 cm
Contraindications to gadolinium contrast
- eGFR < 30 mL/min/1.73m2
- Previous adverse reactions to gadolinium
- Overlapping emphysemic disease where the emphysema-component outweighs the fibrosis
- Unable to perform breath-hold of minimum 20 seconds.
- Allergy to Xenon
- Breast feeding
- Evidence of ongoing respiratory infections at time of MR examinations
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Xenon gas transfer
Time Frame: 12 months
|
Gas transfer across the lung barrier measured using dissolved phase Xe-129 gas MRI spectroscopy. From this measure we expect to see an increase in the tissue signal and a decrease in the blood signal as a measure of IPF disease activity. We expect the change in ratio to be more than 10% when comparing baseline results to follow-up at subject level. Results will be compared to clinical outcome measures of progression (outcome 2) |
12 months
|
Individual clinical progression in the study period (progressors and non-progressors)
Time Frame: 12 months
|
Current accepted criteria for progression of fibrosing interstitial lung diseases (at least 2 of 3):
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary perfusion
Time Frame: 12 months
|
Regionally decreased pulmonary perfusion in ml/g/min measured by gadolinium enhanced MRI
|
12 months
|
Myocardial strain
Time Frame: 12 months
|
Evidence of myocardial strain measured by relative myocardial deformation through the cardiac cycle in percentage with CINE MRI
|
12 months
|
Fibrous tissue formation
Time Frame: 12 months
|
Formation of fibrotic tissue measured with late-contrast enhancement and evaluated as MRI signal intensity changes before and after intravenous gadolinium injection.
|
12 months
|
Xenon ventilation distribution
Time Frame: 12 months
|
Ventilation defect is measured by xenon gas distribution in the lungs.
Ventilation defect percentage is quantified by xenon MRI signal divided by whole lung volume.
|
12 months
|
Xenon gas diffusion
Time Frame: 12 months
|
The diffusion of xenon gas in the alveoli.
Gas diffusion is measured with diffusion-weighted xenon MRI as gas-molecule speed (cm/s)
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elisabeth Bendstrup, Professor, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Xe-F-ILD-001
- 2022-502512-36-00 (Other Identifier: European Medicines Agency (EU CT))
- U1111-1284-7436 (Registry Identifier: Universal Trial Number (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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