Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis (NCT07572383) | Clinical Trial Compass
RecruitingPhase 2
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
United States15 participantsStarted 2026-04
Plain-language summary
The purpose of this study is to investigate how immunosuppression treatment affects measurements of active collagen deposition using \[68Ga\]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in individuals with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD).
Who can participate
Age range18 Years – 80 Years
SexALL
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
✓. Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ILD.
✓. Starting immunosuppression treatment with mycophenolate mofetil, mycophenolate sodium, and / or prednisone for clinically indicated non-IPF ILD treatment.
✓. Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on high-resolution computed tomography (HRCT) performed within 1 year to or at Visit 1.
✓. Forced vital capacity (FVC) of \>/= 45% and diffusing capacity of the lungs for carbon monoxide (DLCO) \>/= 25% predicted on PFTs performed at Visit 1.
Exclusion criteria
✕. Current or prior exposure to FDA approved anti-fibrotic therapy.
✕. Extent of emphysema greater than extent of fibrosis.
✕. Pregnancy or plans to become pregnant at baseline or during follow-up.
✕. Contraindications to MRI.
✕. Contraindications to receiving gadolinium-based contrast agents.
✕. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior year.
✕. Estimated glomerular filtration rate (eGFR) \< 30 mL/min (only for individuals with a history of chronic kidney disease).
What they're measuring
1
Change in SUVmax25 over the entire lungs
Timeframe: From baseline to 12 weeks
2
Change in the rate of contrast washin (kwashin) over the entire lungs