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Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Lung Fibrosis in Participants With Non-Idiopathic Pulmonary Fibrosis Interstitial Lung Disease
Who can join
Ages 18 to 80 · All sexes
Full 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.
About the study
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).
What is being tested
- [68Ga]CBP8 (drug)
- Gadoterate Meglumine (drug)
Sponsor: Peter Caravan · Participants: 15 · Started: May 14, 2026
Contact the study team
- Sydney Montesi, MD · Phone: 617 724 4030
- Caroline Fromson · Phone: 617 643 3260
Official record on ClinicalTrials.gov — NCT07572383
Locations in the U.S.
| Massachusetts | Massachusetts General Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.