Actively Recruiting
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
Led by Peter Caravan · Updated on 2026-05-07
15
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
P
Peter Caravan
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years 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.
- Pulmonary fibrosis shown by honeycombing, traction bronchiectasis, or reticular opacities on high-resolution CT within 1 year or at Visit 1.
- Forced vital capacity (FVC) of 45% or higher and diffusing capacity of the lungs for carbon monoxide (DLCO) of 25% or higher predicted on pulmonary function tests at Visit 1.
You will not qualify if you...
- 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 exceeding 50 millisievert (mSv) in the prior year.
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min for those with chronic kidney disease.
- Clinically significant pulmonary hypertension defined by use of pulmonary vasodilatory therapy.
- Respiratory infection within the prior 6 weeks.
- Smoking of any kind within the prior 6 months.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Sydney Montesi, MD
CONTACT
C
Caroline Fromson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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