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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
71
positron emission tomography (PET)/computed tomography (CT) imaging
University of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGAssess 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
Incidence and severity of adverse events using CTCAE version 5.0 (Both Cohorts)
Purpose is to evaluate the safety and tolerability of \[18F\]FPyQCP
Time frame: From screening until safety follow-up (48 hours post injection)
Further assess the diagnostic performance of [18F]FPyQCP (Cohort B).
Participant and region level diagnostic performance (where calculable: sensitivity, specificity, positive predictive value, and negative predictive value) with \[18F\]FPyQCP PET/CT compared to composite SOT and participant and region level detection rates.
Time frame: Until completion of follow-up procedures, up to 42 days post injection
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