Mechanistic 129 Xe MRI Study to Assess Therapeutic Response in Fibrotic Interstitial Lung Disease

NCT07786090 | Not Yet Recruiting

• 1 other identifier: ROB0064
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to better understand how treatment affects the lungs of adults (ages 18-80) with fibrotic interstitial lung diseases. The main questions it aims to answer are:

• Can advanced imaging detect the effect of currently approved therapies on people with fibrotic interstitial lung diseases?
• What is the relationship between the response to therapy and the imaging response to therapy?

Conditions

Fibrotic Interstitial Lung Disease

Keywords

Hyperpolarized 129Xe MRI; MRI; Pulmonary Function Testing; fILD; Fibrotic Interstitial Lung Disease; Antifibrotic Therapy; Therapeutic Response

Outcome Measures

Primary Outcomes (1)

• Measure 129Xe imaging ventilation defects qualitatively and quantitatively in participants diagnosed with fibrotic interstitial lung disease.

  The extent and timing of clinical and imaging-based physiologic changes following treatment initiation for fibrotic interstitial lung disease will be assessed using conventional assessments and advanced pulmonary imaging (MRI and CT). Measurements will include 129Xe compartment-specific physiologic abnormalities and ventilation defect percent (VDP), Pulmonary Function Test (PFT) including Forced Vital Capacity (FVC), Total Lung Capacity (TLC) and Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), Six-Minute Walk Test (6MWT), symptom scores from St George's Respiratory Questionnaire (SGRQ-I) and King's Brief Interstitial Lung Disease (KBILD) questionnaires, CT parenchyma/airway/vessel morphology.

  3 visits; Visit 1 at baseline, before treatment initiation. Visit 2 at 24 weeks post-treatment initiation. Visit 3 at 48 weeks post treatment initiation. Each visit will include MRI and CT imaging, Blood test, PFT, questionnaires and 6MWT.

Secondary Outcomes (1)

• Determine the relationships between clinical and imaging response to therapy and generate predictive models for their achievement at 1-year using baseline markers and their changes at 24 weeks.

  From baseline to 1 year post-therapy initiation.

Study Arms (1)

Fibrotic Interstitial Lung Disease

Other: Hyperpolarized 129Xe MRI

Interventions

Hyperpolarized 129Xe MRI OTHER

Inhalation of hyperpolarized 129Xe gas followed by breath-hold MRI for ventilation imaging.

Fibrotic Interstitial Lung Disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be adults 18-80 years of age with physician-diagnosed fibrotic interstitial lung disease consistent with 2022 ATS/ERS guidelines and are eligible for antifibrotic therapy. Participants will be referred from respirologists at LHSC London outpatient respirology clinics.

You may qualify if:

• Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature.
• Provision of written, informed consent prior to any study specific procedures.
• Males and females \>/= 18 years of age
• Patient has a current diagnosis of fILD by a respirologist according to the 2022 ATS/ERS guidelines and is eligible for antifibrotic therapy.
• Women of childbearing potential must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit.
• Women of childbearing potential must agree to use a highly effective form of birth control from enrollment, throughout the study duration, with negative urine pregnancy test result at Visits 1, 2, and 3.

You may not qualify if:

• Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants)
• In the investigator's opinion, subject suffers from any physical, psychological or other conditions that might prevent performance of the MRI or CT, such as severe claustrophobia.
• Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.
• Participant is unable to perform spirometry or plethysmography maneuvers.
• Participant is unable to perform MRI and CT breath-hold maneuvers.

Sponsors & Collaborators

• Dr. Grace Parraga: lead

Study Sites (1)

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

London, Ontario, N6A 5B7, Canada

Location

Study Officials

• Grace E Parraga, PHD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace E Parraga, PhD

CONTACT

519-931-5265; gparraga@robarts.ca

Andraena K Tilgner, BHSc., RRT

CONTACT

519-661-2111; atilgner@uwo.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)