Advanced imaging to see how immunosuppression affects lung fibrosis activity

Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Lung Fibrosis in Participants With Non-Idiopathic Pulmonary Fibrosis Interstitial Lung Disease

This trial will test whether immunosuppression changes PET and MRI measurements of active collagen deposition and tissue injury in people with non‑IPF interstitial lung disease who are starting treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07572383 on ClinicalTrials.gov

What this trial studies

Fifteen adults with non‑IPF interstitial lung disease who are starting clinically indicated immunosuppression will undergo targeted molecular PET ([68Ga]CBP8) and dynamic contrast‑enhanced MRI (DCE‑MRI) before treatment and 12 weeks after initiation. The PET tracer binds to actively deposited collagen while DCE‑MRI provides measures of tissue injury and perfusion, allowing paired comparison of imaging biomarkers pre‑ and post‑therapy. Participants will be treated with mycophenolate (or its salts) and/or prednisone as prescribed by their clinicians, with imaging timed around treatment start. The study is single‑center and conducted at Massachusetts General Hospital with NHLBI collaboration.

Who should consider this trial

Good fit: Adults 18–80 with non‑IPF ILD (chronic hypersensitivity pneumonitis, connective tissue‑related ILD, or undifferentiated ILD) who are starting mycophenolate and/or prednisone, have CT evidence of fibrosis, and have FVC ≥45% and DLCO ≥25% predicted are the intended candidates.

Not a fit: People with idiopathic pulmonary fibrosis, prior or current use of antifibrotic drugs, emphysema exceeding fibrosis, severe lung function impairment (FVC <45% or DLCO <25%), pregnancy, or contraindications to MRI are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could give clinicians a noninvasive way to see whether immunosuppression is reducing active collagen deposition and tissue injury, helping tailor treatment decisions.

How similar studies have performed: Targeted collagen PET tracers and DCE‑MRI have encouraging preclinical and early human feasibility data, but using them together to track immunosuppression response in non‑IPF ILD is relatively novel and not yet widely validated.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Starting immunosuppression treatment with mycophenolate mofetil, mycophenolate sodium, and / or prednisone for clinically indicated non-IPF ILD treatment.
3. 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.
4. 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:

1. Current or prior exposure to FDA approved anti-fibrotic therapy.
2. Extent of emphysema greater than extent of fibrosis.
3. Pregnancy or plans to become pregnant at baseline or during follow-up.
4. Contraindications to MRI.
5. Contraindications to receiving gadolinium-based contrast agents.
6. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior year.
7. Estimated glomerular filtration rate (eGFR) \< 30 mL/min (only for individuals with a history of chronic kidney disease).
8. Clinically significant pulmonary hypertension (PH) defined by use of pulmonary vasodilatory therapy.
9. Respiratory infection within the prior 6 weeks.
10. Smoking of any kind within the prior 6 months.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Sydney Montesi, MD — Massachusetts General Hospital
• Study coordinator: Sydney Montesi, MD

Conditions Interstitial Lung Disease; Pulmonary Fibrosis