A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Summary
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \[18F\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
Arms & interventions
- Drug[18F]FPyQCP
positron emission tomography (PET)/computed tomography (CT) imaging
Outcome measures
Primary
Assess radiation dosimetry of [18F]FPyQCP (Cohort A)
Whole body effective dose of a single dose of \[18F\]FPyQCP
Time frame: Up to 360 minutes post injection
Assess the diagnostic performance of [18F]FPyQCP in the peritoneum (Cohort B)
Sensitivity and specificity of \[18F\]FPyQCP PET/CT compared to composite standard of truth
Time frame: Until completion of follow-up procedures, up to 42 days post injection
Secondary
Incidence and severity of adverse events using CTCAE version 5.0 (Both Cohorts)
Time frame: From screening until safety follow-up (48 hours post injection)
Further assess the diagnostic performance of [18F]FPyQCP (Cohort B).
Time frame: Until completion of follow-up procedures, up to 42 days post injection
Eligibility criteria
Study locations (1)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390