Advanced Imaging for Pulmonary Fibrosis

This study is testing a new imaging technique to see if it can help doctors better understand and treat people with pulmonary fibrosis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: rituximab, radiation, prednisone
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06532071 on ClinicalTrials.gov

What this trial studies

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Who should consider this trial

Good fit: Unknown

Not a fit: Unknown

Why it matters

Potential benefit: Unknown

How similar studies have performed: Unknown

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. On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, mycophenolate sodium, and/or rituximab) for at least 3 months.
3. Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.
4. FVC of \>/= 45% and 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 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 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 Pulmonary Fibrosis