This is a prospective exploratory biodistribution study in patients with interstitial lung disease (ILD).
The purpose of this research study is to determine where and to which degree the FAPI tracer (68Ga-FAPI-46) accumulates in normal and fibrotic lung tissues of patients with interstitial lung disease.
The study will include patients with interstitial lung disease who have or will initiate a new ILD medication OR will undergo tissue biopsy or surgery of the lung.
The study will include 30 patients, the upper limit for PET imaging studies conducted under the Radioactive Drug Research Committee (RDRC) purview.
Participants will be injected with up to 7 mCi of 68-GaFAPi and will undergo one PET/CT scan and one High Resolution CT of the lungs.
The study is sponsored by Ahmanson Translational Theranostic Division at UCLA.
Patients with ILD confirmed by CT at time of staging
Patients who have initiated or will initiate a new ILD medication with 3 months of enrollment OR Patients who are scheduled to undergo tissue biopsy or surgery of the lung
Patients are ≥ 18 years old at the time of the radiotracer administration
Patient can provide written informed consent
Patient is pregnant or nursing
Patients with active infectious lung disease
Patients not expected to comply with the protocol requirements, not able to understand or follow trial procedures
Single group
68Ga-FAPi-46
DrugRadiopharmaceutical will be administered via IV
Computed Tomography
Procedure/SurgeryAs part of PET/CT scan
Positron Emission Tomography
Procedure/SurgeryAs part of PET/CT scan
High Resolution Computed Tomography
Procedure/SurgeryWill be conducted immediately after FAPI PET/CT
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease
To quantify diseased tissue and normal background organs, 68Ga-FAPI-46 positron emission tomography (PET) tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).
68Ga-FAPi-46 accumulation
To evaluate the degree of 68Ga-FAPi-46 accumulation observed by PET imaging as opposed to the amount of FAP expression in obtained lung tissue, when available. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
68Ga-FAPi-46 and disease progression
To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with disease progression under ILD therapies.
68Ga-FAPi-46 biodistribution
To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with HR CT quantitative parameters
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