PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation

What this Trial Is About

This research aims to explore how the FAPI tracer 68Ga-FAPI-46 distributes within the lungs of patients diagnosed with interstitial lung disease (ILD). ILD affects the lung interstitium and varies widely in progression, with some patients remaining stable and others worsening despite treatment. The study focuses on whether this tracer can identify areas of active tissue remodeling linked to fibroblast activation, a key feature of lung fibrosis. Participants will receive an intravenous injection of up to 7 mCi of 68Ga-FAPI-46, followed by a PET/CT scan lasting between 20 to 50 minutes. Immediately after, a High Resolution CT scan of the lungs will be performed. Patients included in the study either have started or will start new ILD medication within 3 months of enrollment or are scheduled for lung tissue biopsy or surgery. The study will include 30 patients and is conducted under the Radioactive Drug Research Committee guidelines. During the study, participants will undergo imaging evaluations to assess the tracer’s accumulation in lung tissues. Researchers will compare these imaging results with pathological findings from biopsies or surgeries when available. The primary outcome is to document the biodistribution of 68Ga-FAPI-46 within 60 minutes after injection. Secondary outcomes include tracking tracer accumulation and its relation to disease progression over up to two years. The study is sponsored by the Ahmanson Translational Theranostic Division at UCLA.

FAPI PET for Lung Fibrosis