Hyperpolarized 129-Xenon MRI in Fibrosing Interstitial Lung Disease

NCT05914506 | Active Not Recruiting DMC

• 3 other identifiers: Xe-F-ILD-0012022-502512-36-00U1111-1284-7436
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Progressive Fibrosing Interstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

• Xenon gas transfer

  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)

  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.

  12 months

Secondary Outcomes (5)

• Pulmonary perfusion

  12 months

• Myocardial strain

  12 months

• Fibrous tissue formation

  12 months

• Xenon ventilation distribution

  12 months

• Xenon gas diffusion

  12 months

Interventions

Hyperpolarized xenon-129 MRI DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have recently recieved a diagnosis of progressive fibrosing interstial lung disease and are expected to recieve antifibrotic therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University, Department of Clinical Medicine, MR Research Centre

Aarhus, 8200, Denmark

Location

Study Officials

• Elisabeth Bendstrup, Professor

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: June 22, 2023
• Study Start: October 5, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)