Hyperpolarized 129-Xenon MRI in Fibrosing Interstitial Lung Disease
Denmark30 participantsStarted 2023-10-05
Plain-language summary
This project aims to investigate the potential of non-invasive imaging to identify and monitor the earliest signs and physiological effects of pulmonary fibrosis and resulting cardiac dysfunction in patients with fibrosing interstitial lung disease. Second, to evaluate baseline risk factors the progression and therapeutic responses to anti-fibrotic drugs.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Xenon gas transfer
Timeframe: 12 months
2
Individual clinical progression in the study period (progressors and non-progressors)