This is a single arm prospective pilot trial that evaluates the ability of a novel imaging agent (68Ga-FAP-2286) to identify pathologic fibrosis in the setting of hepatic, cardiac and pulmonary fibrosis. FAP-2286 is a peptide that potently and selectively binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on fibroblasts and has been shown to have higher expression in idiopathic pulmonary fibrosis (IPF), cirrhosis, and cardiac fibrosis.
PRIMARY OBJECTIVES: I. All cohorts: Safety of 68Ga-FAP-2286. II. Cohort 1: Measured uptake of radiotracer (SUVpeak) in regions of known liver fibrosis. III. Cohort 2: Measured uptake of radiotracer (SUVpeak) in regions of known pulmonary fibrosis. IV. Cohort 3: Measured uptake of radiotracer (SUVpeak) in regions of myocardial fibrosis. EXPLORATORY OBJECTIVES: I. Correlation of 68Ga-FAP-2286 uptake with FAP expression determined by immunohistochemistry. II. Compare 68Ga-FAP-2286 scan results to archival Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET) images. Patients will receive a single administration of 68Ga-FAP-2286 prior to PET imaging and will be followed for up to two hours after the injection of 68Ga-FAP-2286 for evaluation of adverse events.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Imaging will begin 50-100 minutes after injection and last about 45 minutes.
University of California, San Francisco
San Francisco, California, United States
Proportion of participants with treatment-related adverse events
Proportion of participants with Adverse Events, as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 will be reported.
Time frame: Up to 31 days
Median peak standardized uptake value (SUVpeak) in liver region
The median SUVpeak in regions of known liver fibrosis will be reported with 95% confidence intervals
Time frame: Up to 1 days
Median peak standardized uptake value (SUVpeak) in lung region
The median SUVpeak in regions of known pulmonary fibrosis will be reported with 95% confidence intervals
Time frame: Up to 1 days
Median peak standardized uptake value (SUV) in myocardium region
The median SUVpeak in regions of known myocardial fibrosis will be reported with 95% confidence intervals
Time frame: Up to 1 days
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