Advanced Imaging for Pulmonary Fibrosis
ConditionPulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeter Caravan
About this trial
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 resonance imaging (DCE-MRI) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) and identify which individuals will develop progressive pulmonary fibrosis.
Eligibility criteria
Qualifiers
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, mycophenolate sodium, 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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- [68Ga]CBP8
- Gadoterate Meglumine
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Peter Caravan
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Source ClinicalTrials.gov