Hyperpolarized xenon-129 MRI: Participants will be asked to inhale the xenon-129 contrast agent according to procedure for gas administration. The success criterion of the drug is a obtained Xe MRI lung image with reasonable signal level
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Xenon gas transfer — 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)
Individual clinical progression in the study period (progressors and non-progressors) — 12 months Current accepted criteria for progression of fibrosing interstitial lung diseases (at least 2 of 3):
1. Worsening of clinical symptoms (estimated by qualified physician. Additionally this will be quantified by patient related outcome measures, (K-BILD, SOBQ and L-PF)
2. Decline in pulmonary function test parameters (decrease of FVC \>= 5% and/or DLCO \>= 10%)
3. Radiological evidence of disease progression:
1. Increased extent or severity of traction bronchiectasis and bronchiolectasis
2. New ground-glass opacity with traction bronchiectasis
3. New fine reticulation
4. Increased extent or increased coarseness of reticular abnormality
5. New or increased honeycombing
6. Increased lobar volume loss.
Trial sites (1)
Facility
City
Region
Status
Aarhus University, Department of Clinical Medicine, MR Research Centre
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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