Mechanistic 129 Xe MRI Study to Assess Therapeutic Response in Fibrotic Interstitial Lung Disease (MASTER-ILD)
25 augusti 2026 uppdaterad av: Dr. Grace Parraga
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?
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a prospective, single site, observational study in adults aged 18-80 who have fibrotic interstitial lung disease (fILD), and are scheduled to start antifibrotic therapy as prescribed by their treating respirologist. Therapeutic treatment will be assigned in a non-randomized manner by the treating respirologist. There will be no control intervention or blinding.
Each participant will participate in three study visits over a one-year period; Visit 1 - before start of treatment Visit 2 - after 24 weeks of therapy Visit 3 - after 48 weeks of therapy
Each visit will include; a blood test - Complete Blood Count (CBC), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR); Pulmonary Function testing (PFT) that includes spirometry, plethysmography, diffusion capacity, oscillometry; urine pregnancy test (if indicated); St George's Respiratory Questionnaire (SGRQ-I) and King's Brief Interstitial Lung Disease (K-BILD) questionnaire; 129Xenon Magnetic Resonance Imaging (129Xe MRI); Low-dose chest Computed Tomography (CT) /High Resolution Computed Tomography (HRCT) scan; Six-Minute Walk Test (6MWT) with Borg rating of perceived exertion and dyspnea (BORG) questionnaires.
Studietyp
Observationell
Inskrivning (Beräknad)
35
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Grace E Parraga, PhD
- Telefonnummer: 519-931-5265
- E-post: gparraga@robarts.ca
Studera Kontakt Backup
- Namn: Andraena K Tilgner, BHSc., RRT
- Telefonnummer: 89853 519-661-2111
- E-post: atilgner@uwo.ca
Studieorter
-
-
Ontario
-
London, Ontario, Kanada, N6A 5B7
- Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
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Huvudutredare:
- Grace Parraga, PhD
-
Kontakt:
- Grace Parraga, PhD
- Telefonnummer: 519-931-5265
- E-post: gparraga@uwo.ca
-
Kontakt:
- Andraena K Tilgner, BHSc., RRT
- Telefonnummer: 89853 519-661-2111
- E-post: atilgner@uwo.ca
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Fibrotic Interstitial Lung Disease
|
Inandning av hyperpolariserad 129xe-gas följt av andningshåll MRI för ventilationsavbildning.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measure 129Xe imaging ventilation defects qualitatively and quantitatively in participants diagnosed with fibrotic interstitial lung disease.
Tidsram: 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.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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.
Tidsram: From baseline to 1 year post-therapy initiation.
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Observe changes in 129Xe compartment-specific physiologic abnormalities, changes in ventilation defect percent (VDP), Changes in CT (for progression in fibrotic disease), PFT, 6MWT, SGRQ-I, KBILD.
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From baseline to 1 year post-therapy initiation.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Grace E Parraga, PHD, Robarts Research Institute, The University of Western Ontario
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 november 2026
Primärt slutförande (Beräknad)
1 november 2028
Avslutad studie (Beräknad)
1 januari 2029
Studieregistreringsdatum
Först inskickad
20 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2026
Första postat (Faktisk)
25 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ROB0064
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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