Status:
RECRUITING
Advanced Imaging for Pulmonary Fibrosis
Lead Sponsor:
Peter Caravan
Conditions:
Pulmonary Fibrosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if measurements of active collagen deposition using \[68Ga\]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic...
Detailed Description
60 participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) on stable dose immunosuppression treatment will be enrolled. Participants will undergo combined \[68Ga\]C...
Eligibility Criteria
Inclusion
- 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.
- On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, and/or rituximab) for at least 3 months.
- Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.
- FVC of \>/= 45% and DLCO \>/= 25% predicted on PFTs performed at Visit 1.
Exclusion
- 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 mSv in the prior year.
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min (only for individuals with a history of chronic kidney disease).
- Clinically significant PH defined by use of pulmonary vasodilatory therapy.
- Respiratory infection within the prior 6 weeks.
- Smoking of any kind within the prior 6 months.
Key Trial Info
Start Date :
January 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06532071
Start Date
January 21 2025
End Date
December 31 2028
Last Update
March 26 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114